MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Catalog Number	07P99-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier multiple = (b)(6).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.
Event or Problem Description
The customer reported falsely elevated alinity c creatinine results on three patients.The results provided were: sid (b)(6) = 2.52mg/dl / 0.93mg/dl; sid (b)(6) = 2.52mg/dl / repeated = 0.91mg/dl; sid (b)(6) = 20.6mg/dl / repeated = 86.6mg/ dl (normal range 0.20 to 37.00mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review for similar tickets for lot 86377un18 found no other complaints and no trends related to this issue for the product.Return testing was not completed as returns were not available.The alinity c system operations manual provides troubleshooting for results issues, which includes the possibility of expired reagents as a probable cause.The manual also provides cautions against using expired reagent.The system also alerts the user if reagent is expired.Use error caused the issue as the customer used expired reagent when they reported the discrepant results.Once the customer recalibrated r1 and r2, cleaned cuvettes and replaced the water in the water bath, the issue did not recur.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on our investigation no product deficiency was identified for the alinity c creatinine, lot 86377un18.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9539771
• Report Number: 3002809144-2020-00001
• Device Sequence Number: 14024125
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2019
• Device Catalogue Number: 07P99-30
• Device Lot Number: 86377UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C PROCESSING MODULE,; ALINITY C PROCESSING MODULE, LN 03R67-01,; LN 03R67-01, SERIAL # (B)(6); SERIAL # (B)(6)