MAUDE Adverse Event Report: ABBOTT GMBH 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 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.

Event Description

The customer reported a (b)(6) alinity c creatinine result on one male patient.The results provided were on (b)(6) 2020 initial = 400umol/l (normal is 110) / retest the next day on a new sample, same patient = 73umol/l.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets by lot 26956un20 found no other complaints for this issue.Trending review determined no trends for elevated patient results due to the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations for lot 26956un20 and the complaint issue.A review of product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of alinity c creatinine reagent, lot number 26956un20 was identified.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11065926
• MDR Text Key: 240618761
• Report Number: 3002809144-2020-01207
• 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: 01/08/2021

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: 05/26/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 26956UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Age: 30 YR