MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I TACROLIMUS REAGENT KIT; ENZYME IMMUNOASSAY, TRACROLIMUS

Catalog Number	09P42-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based upon new information, this complaint is no longer a reportable event.Additional information can be found in section b5.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any non-conformances, potential nonconformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity.Trending review did not identify any trends.In-house testing was conducted with an in-house retained kit of lot 59938fp00 and passed testing criteria.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency of the alinity i tacrolimus reagent lot 59938fp00.
Event or Problem Description
The customer reported falsely elevated alinity i tacrolimus for a 60-year-old female that received a stem cell transplant on (b)(6).The customer has sent out samples in question to other laboratories who repeated with different method or platform.The customer provided the following data: patient received a 1 mg dose of tacrolimus on (b)(6).Patient was scheduled to receive a dose on (b)(6) in the morning and it was held due to the elevated result (22.6).Patient did not receive another dose (0.5 mg) until (b)(6) at 20:30.The customer was not aware of any harm to the patient.Patient normal dosing is 2x/day.Customer reference range 5-15 ng/ml; toxic range is >22 ng/ml; critical range is >30 ng/ml on (b)(6) 2024 the alinity result was 12.2 on (b)(6) 2024 the alinity result was 27 on (b)(6) 2024 the alinity result was 22.6 and the comparison test at another laboratory was 13.9.On (b)(6) 2024 the alinity result was 16.3 on (b)(6) 2024 the alinity result was 14.2 and the comparison test at another laboratory was 7.2.On (b)(6) 2024 the alinity result was 6.3 and the comparison test at another laboratory was 4.1 on (b)(6) 2024 the alinity result was 7.1 and the comparison test at another laboratory was 5.1 on (b)(6) 2024 the alinity result was 9.5 and the comparison test at another laboratory was 6.2 on (b)(6) 2024 the alinity result was 15.2 and repeat on another alinity was 15.3 and the comparison test at another laboratory was 14.4 on (b)(6) 2024 the alinity result was 10.8 and the comparison test at another laboratory was 7.7.The customer was not aware of any harm that came to the patient due to withholding the dosage and there was no further reported impact on patient management.Update: additional information provided by the customer: the patient's medications and laboratory tests were provided.Upon review of the patients' medications, the patient was taking multiple immunosuppressive drugs post bone marrow transplant and therefore had continuous immunosuppressive therapy while the tacrolimus therapy was temporarily stopped.The customer also reported that the tacrolimus levels have been accurate on other non-stem cell transplant patients, and the customer further elaborated that they feel that the tacrolimus discrepancy can be due to interference from patient drug interaction or metabolites.Medications: acyclovir ¿ 300 mg, 6ml.Cefepime ¿ 2 g, 10 ml.Clonazepam ¿ 0.5 mg.Furosemide ¿ 40 mg.Letermovir ¿ 40 mg, 4 ml.Magnesium sulfate ¿ 4 g.Metronidazole ¿ 500 mg.Pantoprazole ¿ 40 mg.Posaconazole ¿ 300 mg.Potassium ¿ 40 meq.Tacrolimus last dose 1 mg on (b)(6) 2024 at 0626 and held until (b)(6) at 2030 (0.5 mg).Tbo-filgrastim ¿ 480 mcg.Ursodiol ¿ 300 mg.Acetaminophen 300 mg.Hydromorphone ¿ 0.3 mg.Continuous infusion d5w ¿ 1000 ml.Lactated ringers ¿ 1000 ml.Additional laboratory data: date (b)(6) 2024: creatinine (mg/dl) was 1.28, gfr was 48, & bun (mg/dl) was 28 date (b)(6) 2024: creatinine (mg/dl) was 1.06, gfr was 60, & bun (mg/dl) was 26 date (b)(6) 2024: creatinine (mg/dl) was 1.01, gfr was 64, & bun (mg/dl) was 27 date (b)(6) 2024: creatinine (mg/dl) was 0.88, gfr was 75, & bun (mg/dl) was 26 date (b)(6) 2024: creatinine (mg/dl) was 0.77, gfr was 88, & bun (mg/dl) was 21 date (b)(6) 2024: creatinine (mg/dl) was 0.7, gfr was 99, & bun (mg/dl) was 13 date (b)(6) 2024: creatinine (mg/dl) was 0.7, gfr was 99, & bun (mg/dl) was 9 date (b)(6) 2024: creatinine (mg/dl) was 0.75, gfr was 91, & bun (mg/dl) was 7 date (b)(6) 2024: creatinine (mg/dl) was 0.86, gfr was 77, & bun (mg/dl) was 11 date (b)(6) 2024: creatinine (mg/dl) was 0.89, gfr was 74, & bun (mg/dl) was 13 date (b)(6) 2024: creatinine (mg/dl) was 0.88, gfr was 75, & bun (mg/dl) was 13 date (b)(6) 2024: creatinine (mg/dl) was 0.85, gfr was 78, & bun (mg/dl) was 14.
Event or Problem Description
The customer reported falsely elevated alinity i tacrolimus for a 60 year old female that received a stem cell transplant on (b)(6).The customer has sent out samples in question to other laboratories who repeated with different method or platform.The customer provided the following data: patient received a 1 mg dose of tacrolimus on 4/8.Patient was scheduled to receive a dose on 4/9 in the morning and it was held due to the elevated result (22.6).Patient did not receive another dose (0.5 mg) until 4/12 at 20:30.The customer was not aware of any harm to the patient.Patient normal dosing is 2x/day.Customer reference range 5-15 ng/ml; toxic range is >22 ng/ml; critical range is >30 ng/ml on 4/6/2024 the alinity result was 12.2 on 4/8/2024 the alinity result was 27 on 4/9/2024 the alinity result was 22.6 and the comparison test at another laboratory was 13.9 on 4/10/2024 the alinity result was 16.3 on 4/11/2024 the alinity result was 14.2 and the comparison test at another laboratory was 7.2 on 4/12/2024 the alinity result was 6.3 and the comparison test at another laboratory was 4.1 on 4/14/2024 the alinity result was 7.1 and the comparison test at another laboratory was 5.1 on 4/15/2024 the alinity result was 9.5 and the comparison test at another laboratory was 6.2 on 4/18/2024 the alinity result was 15.2 and repeat on another alinity was 15.3 and the comparison test at another laboratory was 14.4 on 4/22/2024 the alinity result was 10.8 and the comparison test at another laboratory was 7.7.The customer was not aware of any harm that came to the patient due to withholding the dosage and there was no further reported impact on patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ALINITY I TACROLIMUS REAGENT KIT
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19287257
• Report Number: 1415939-2024-00042
• Device Sequence Number: 18052358
• Product Code: MLM
• UDI-Device Identifier: 00380740154516
• UDI-Public: (01)00380740154516(17)250513(10)59938FP00
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K070820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2025
• Device Catalogue Number: 09P42-20
• Device Lot Number: 59938FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female