MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 07P9930

Device Problem High Test Results (2457)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = (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 due to privacy issues.

Event Description

The customer reported falsely elevated alinity c creatinine results on one patient.The results provided were: on (b)(6) 2021 (b)(6) initial = 9.35mg/dl (normal range 0.72-1.25mg/dl) / retest after 30 minutes = 0.73mg/dl.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot number 02995un20.Trending review determined no trends for elevated patient results due to the product.Return testing was not completed as returns were not available.File sample analysis was not performed as retesting of the sample gave expected normal results.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 alinity creatinine reagent, lot number 02995un20 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: 11250469
• MDR Text Key: 229391845
• Report Number: 3002809144-2021-00068
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• 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: 02/08/2021

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: 01/10/2022
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 02995UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC02027; ALNTY C PROCESSING MODU, 03R67-01, AC02027; ALNTY C PROCESSING MODU, 03R67-01, (B)(4)
• Patient Age: 41 YR