MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number 07P9930

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

An evaluation is in process.A followup report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported a falsely elevated creatinine result generated on the alinity c analyzer on one patient.Results provided: (b)(6) 2020, sid (b)(6) = 428 umol/l, repeated on another alinity c on (b)(6) 2020 = 83 umol/l.Reference range: male (63.6 - 110.5 umol / l) female (50.4 - 98.1 umol / l).No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for alinity creatinine ln 7p99 lot 82385un19.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.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 creatinine ln 7p99 lot 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: 10181512
• MDR Text Key: 228024569
• Report Number: 3002809144-2020-00493
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• 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: 07/07/2020

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: 07P9930
• 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: 06/22/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE LIST 03R67-01; ALINITY C PROCESSING MODULE LIST 03R67-01; SERIAL (B)(6); SERIAL (B)(6)