Model Number 100071 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Bronchitis (1752); Pneumonia (2011)
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Event Date 04/20/2015 |
Event Type
malfunction
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Event Description
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Patient self tester reported lot to lot variability when testing her inratio.Results as follows: ln 362393: (b)(6) 2015 1.6, (b)(6) 2015 4.5; ln 367324: (b)(6) 2015 1.5, (b)(6) 2015 1.2.Patient's therapeutic range: 2-3.Patient was milking finger after finger stick; unable to obtain sufficient blood sample.Patient was hospitalized (b)(6) 2015 for pneumonia, bronchitis; was on antibiotics only during hospitalization.This mdr is for lot 362393a; reference mdr 2027969-2015-00387 for lot 367324.
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Manufacturer Narrative
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It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot #362393a did not uncover any non-conformances.Lot meets release specification.Although improper techniques were identified in the complaint, these could not be ruled out as a possible cause of the unexpected results.In addition, the customer has aps.The customer's blood sample may have interfered with the coagulation test.This may have contributed to the unexpected results observed by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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Manufacturer Narrative
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Lot numbers corrected; each strip lot number needed to include an 'a' at the end.Lot numbers should have been listed as: 362393a and 367324a.Since the meter was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified as part of an internal investigation to contribute to a potential discrepant result.Internal investigation has determined that certain patient conditions ((e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.It was noted that the patient was hospitalized (b)(6) 2015 to (b)(6) 2015 for pneumonia and bronchitis.Chronic inflammatory conditions and acute infections have been identified as conditions that may contribute to a discrepant inr result.
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Event Description
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Patient self tester reported lot to lot variability when testing her inratio.Results are as follows: (b)(6).This mdr is for lot 362393a; reference mdr 2027969-2015-00387 for lot 367324a.Both lot numbers are being corrected since neither had the 'a' at the end.
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Search Alerts/Recalls
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