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 08/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - multiple = (b)(6).There was no additional patient information provided by the customer.A review of tickets determined that there is normal complaint activity for alinity creatinine reagent ln 7p99-20 / lot number 53868un20.Trending review determined no trends for discrepant patient results for the product.Return testing was not completed as returns were not available.Retesting of the sample and another sample were reproducible, indicating a possible issue with the initial sample testing.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 reagent lot number 53868un20 was identified.

Event Description

The customer reported falsely elevated alinity c creatinine results on two patients.The results provided were: on (b)(6) 2020 (b)(6) initial = 6.62mg/dl / retest = 6.78 / after physician questioned retest = 2.63 / new sample, same patient = 1.0 / plasma sample from (b)(6) 2020 = 0.91mg/dl; (b)(6) initial = 5.98 / retest = 4.42mg/dl / after physician questioned = 4.01, 3.99mg/dl / new sample, same patient =0.82mg/dl(normal range male= 0.7 - 1.2, female= 0.5 - 0.9mg/dl).There was no reported impact to patient management.

• Brand Name: ALINITY C CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10514124
• MDR Text Key: 241305891
• Report Number: 3002809144-2020-00905
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2020

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: 09/18/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 53868UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1