MAUDE Adverse Event Report: ABBOTT ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false elevated alinity c creatinine results for a patient.The following data was provided:.On (b)(6) 2020, sid: (b)(6) = creatinine = 2.39 mg/dl, repeat = 2.43 mg/dl.On (b)(6) 2020, customer retested same patient sample, and generated a creatinine result of 1.39 mg/dl.On (b)(6) 2020, sid (b)(6) = creatinine = 1.42 mg/dl (on a different alinity c analyzer), repeat creatinine = 1.71 mg/dl (after re-calibrating on original alinity c analyzer).There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated results for a patient with the alinity c creatinine assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review.A review of tickets determined that there is normal complaint activity for creatinine reagent lot 53923un20.Trending review determined no trends identified for falsely elevated or erratic results for the product.Return testing was not completed as returns were not available.A repeat analysis using the patient sample passed at the customer site and results were as expected.Qc was within range and a precision run found acceptable results.A review of the device history record did not identify any non-conformances or deviations related to the complaint.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity c creatinine reagent, lot number 53923un20 was identified.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10650093
• Report Number: 3002809144-2020-01007
• Device Sequence Number: 3216144
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 53923UN20
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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 C PROCESSING MODU, 03R67-01, AC01258; ALNTY C PROCESSING MODU, 03R67-01, AC01258; ALNTY C PROCESSING MODU, 03R67-01, AC01258