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

Model Number	3L81-33
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11108722
• Report Number: 3002809144-2021-00005
• Device Sequence Number: 3698109
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083809
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: 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