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25 oct 2022: the quality assurance investigation was completed.Manufacturing investigation response: the customer reported unexpected low creatine (cre-) involving the piccolo amlyte 13 panel.(b)(6) 2022 (10:19 pm)- initial whole blood was analyzed with the piccolo express analyzer p21414 and the amlyte 13 rotor lot 1511ab4.The results are reported as follows: creatine (cre) =78 umol/l (reference range: 53-106 umol/l).Sodium (na) = suppressed (reference range: 128-145 mmol/l).The analyzer gave flags due to sodium (na) suppression: *end abs cuv 1; rerun new sample.*ending abs out of range; possibly a high result.If hem, new sample; if not hem, rerun (b)(6) 2022 (10:39 pm)- a second run using the same whole blood sample was run on the piccolo express analyzer p21414 and the amlyte 13 rotor lot 1511ab4.The results reported as follows: creatine (cre) = 46 umol/l (reference range: 53-106 umol/l).Sodium (na)=138 mmol/l (reference range: 128-145 mmol/l).(b)(6) 2022 (8:32 am)- a third run using the same whole blood sample from the previous day was run on the cobas integra analyzer.The results are reported as follows: creatine (cre) = 74 umol/l, sodium (na) =143 mmol/l.(b)(6) 2022 (10:24 am) - a fourth run using the same whole blood sample was run on the piccolo express analyzer using p21414 and the amlyte 13 rotor lot 1511ab4.The results are reported as follows: creatinine (cre) = 81umol (reference range: 53-106 umol/l), sodium (na) = 140 mmol/l (reference range: 128-145 mmol/l).The reporter was concerned about the results obtained from the amlyte 13 rotor (400-0041) lot #1511ab4 on the (b)(6) 2022 with an unexpected low creatine value at 46 umol/l.The customer stated if the provided creatinine (46 umol/l) value was incorrect and the true value was double as measured, a patient could face kidney failure if receiving a contrast agent in advance of a ct.The patient was not given contrast or a ct.Per the information provided by the clinic, the patient was not treated based on the piccolo express chemistry analyzer results.25 oct 2022: the quality assurance investigation was completed.Manufacturing investigation response: abaxis manufacturing performed a batch record review for lot #1511ab4 and there were no non-conformances found during the manufacturing of this lot.The lot met all release criteria with no deviations found during manufacturing.Creatinine complaints received worldwide were reviewed and there was no observed trends for low or high creatinine results identified.Abaxis technical service support followed up on-site with the clinic to discuss the total precision of the creatinine assay on the piccolo platform and whether or not it is sufficient for the clinical needs of this customer.Further follow-up with the customer is expected.The creatinine result of 46 mol/l although slightly below the reference range of 53 mol/l to 106 mol/l would not require any medical action or generate a harmful situation to the patient.Per the package insert instructions, section 10, it is recommended that any result for a particular test that exceeds the assay range should be analyzed by another approved test method or sent to a referral laboratory.The hospital performed retesting by another approved test method per recommendations in the package insert.A follow-up with the customer on 25aug2022 confirmed the customer is still evaluating their process and the product.They currently have no further complaints.In clarification of the %cv; the creatinine (mg/dl) precision studies results reflect the following and are referenced within the amlyte 13 package insert.As indicated below 12.5 is referencing the % cv within a run and 13.1 is the %cv for the total.Analyte: sample size: within run: total: creatinine (mg0dl) n=80.Control 1.Mean: 1.1, 1.1.Sd: 0.14, 0.14.%cv: 12.5, 13.1.The 3sd rule is based on statistical probability.Abaxis met with our medical consultant (dr.(b)(6), md, phd professor of (b)(6) university and clinical pathologist for (b)(6) hospital at u.S.Department of veterans affairs) to evaluate the incident.Dr.(b)(6) completed a risk analysis with the following response: "the variation in creatinine seen in this patient is high for that observed precision, but the values were obtained on two successive days and physiological variation as well as method precision is likely involved.While creatinine is primarily a measure of renal function, creatinine is produced by protein catabolism, though it's not used clinically as a measure of metabolic state.Renal blood flow, protein load and metabolism affect creatinine with normal renal function.Values of creatinine within the lower reaches of the reference interval; all the values seen here; are all [?]normal' values and variation within that range is not uncommon due to method and physiological variation.No medical intervention is required for changes within that low range.Even if the patient were acutely ill and acute renal failure under suspicion, the pattern of changes (.9-.5-.9 and.8) within a very low (and hence physiologically unsuspicious) range points to simple variation, not a trend, and would not spur action or alarm." in conclusion, the low complaint rate ((b)(4)) for the creatinine lot and the medical opinion confirming no medical intervention is required for changes within that low range, it can be concluded the product is performing as expected and does not present a safety risk to patients.Abaxis continues its vigilance activities and monitors products on the markets worldwide for performance and safety in our post-market surveillance program as well as participates in proficiency testing.No preventative or corrective actions are required at this time.The kantonsspital baselland did not treat the patient for low creatinine and also our medical consultant (dr.(b)(6), md, phd professor of laboratory medicine at (b)(6) university and clinical pathologist for (b)(6) hospital at u.S.Department of veterans affairs) confirmed that there was no risk for the patient by the lower creatinine value.So there was neither a deterioration in the patient health nor a delay in the diagnostic and therefore no reportable serious incident related to the patient.A review of the batch record showed that the reported lot #1511ab4 met all quality release criteria within specifications with no deviations during the manufacturing process.A review of the complaint data showed that there were no further complaint for the rotor from this lot, additional to the reported one by the distributor's customer for low cre results out of (b)(4) rotors shipped and released to the market.The calculated complaint rate is (b)(4).There are no indications that the product is operating outside of acceptable specifications.Abaxis continues its vigilance activities and monitors products on the markets worldwide for performance and safety in our post-market surveillance program as well as participates in proficiency testing (e.G.Mqzh).No preventative or corrective actions are required at this time.Abaxis technical services support followed up on site with the clinic and the assay specifications were explained.Abaxis consulted our medical consultant for a patient risk assessment.A follow up with the customer on 25aug2022 confirmed the customer is still evaluating their process and the product.They currently have no further complaints.Abaxis does not claim the deviation of roughly 39% is expected by the user.Abaxis does officially communicate to customers how to address test results that are not expected in the product labeling in section 10 limitations of procedure, with the following warnings: - any result for a particular test that exceeds the assay range should be analyzed by another approved test method or sent to a referral laboratory.Do not dilute the sample and run it again on the piccolo xpress chemistry analyzer.- extensive testing of the piccolo xpress chemistry analyzer system has shown that, in very rare instances, sample dispensed into the reagent disc may not flow smoothly into the sample chamber.Due to the uneven flow, an inadequate quantity of sample may be analyzed and several results may fall outside the reference ranges.The sample may be re-run using a new reagent disc.As described in the event, the user did follow the instructions for use by repeating the value and confirming the value on a different device.Additionally, as previously stated by our medical consultant, "values of creatinine within the lower reaches of the reference interval; all the values seen here; are all normal' values and variation within that range is not uncommon due to method and physiological variation.No medical intervention is required for changes within that low range.Even if the patient were acutely ill and acute renal failure under suspicion, the pattern of changes (.9-.5-.9 and.8) within a very low (and hence physiologically unsuspicious) range points to simple variation, not a trend, and would not spur action or alarm." as indicated previously, abaxis has completed a complaint investigation based on the available data obtained during abaxis' investigation of the incident.Abaxis' request for return of product was not completed by the customer.Based on the available data obtained during the investigation, including information provided by the reporting facility on sample handling, manufacturing, and internal data, and post-market surveillance of complaints for this lot, there was no identified trend, significant failure or lack of performance related to this lot.Therefore, the complaint could not be confirmed.There is no data to indicate a patient safety, quality, or efficacy concern with the complaint lot.The risk assessment for the assay was last updated 07-2022.All risks for the piccolo xpress chemistry analysis system are in the acceptable range including creatinine.
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