MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 3L81-33

Device Problem High Test Results (2457)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Refer to mfr# 3016438761-2021-00001-00 for the analyzer submission.

Event Description

The customer reported falsely elevated potassium and creatinine results generated on the architect c16000 analyzer on a (b)(6) male patient.Results provided: (b)(6) 2020.(b)(6).Potassium = 6.8 / 6.7 mmol/l, new aliquot = 4.6 mmol/l (normal range: 3.5-5.1 mmol/l); creatinine = 451.6 umol/l, new aliquot = 103.1 umol/l.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there was no other complaint activity for creatinine (ln 3l81-33).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 product labeling concluded that the issue is sufficiently addressed.Use error may have contributed to the customer¿s issue as customer has external aliquot samples (2ml) manually uncapped beside manually uncapped urine tubes (10ml).On occasion, if user is forceful with the loading of tubes into rack and racks into iom, a small droplet may 'splash' up 1 centimeter into the aliquot tube behind it.Senior scientist to re-educate staff on appropriate loading of samples and racks.Based on the investigation, no systemic issue or deficiency for the creatinine was identified.

• Brand Name: CREATININE
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11108722
• MDR Text Key: 224813749
• Report Number: 3002809144-2021-00005
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• 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: 02/23/2021

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 Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600805; ARC C16K PRC MOD, 03L77-01, C1600805; ARC C16K PRC MOD, 03L77-01, C1600805
• Patient Age: 53 YR