MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number 07P9920

Device Problem High Test Results (2457)

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

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated creatinine on alinity c processing module for multiple patients.The results were provided: on (b)(6) 2020 sid (b)(6) creatinine=177 umol/l on (b)(6) 2020 repeated on another alinity =98 umol/l(% difference=81%) (laboratory reference range for men=63.6 to 110.5 umol/l and women=50.4 to 98.1 umol/l).There was no reported impact to patient management.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting, a search for similar complaints, instrument service history review, and a review of product labeling.A review of tickets was performed for alinity creatinine reagent lot number 82385un19.The ticket search found no complaints similar to this issue.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the creatinine assay lot number 82385un19 was identified.

• Brand Name: ALINITY C CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10203144
• MDR Text Key: 222187681
• Report Number: 3002809144-2020-00533
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• 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: 07/08/2020

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: 03/04/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 82385UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE; ALINITY C PROCESSING MODULE; LIST # 03R67-01, SERIAL # (B)(6); LIST # 03R67-01, SERIAL # (B)(6)