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

Model Number 07P9920

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10650093
• MDR Text Key: 210496343
• Report Number: 3002809144-2020-01007
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• PMA/PMN Number: K083809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 53923UN20
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01258; ALNTY C PROCESSING MODU, 03R67-01, AC01258; ALNTY C PROCESSING MODU, 03R67-01, AC01258