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

Model Number	3L81-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
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.Patient identifier complete sid: (b)(6).
Event or Problem Description
The customer reported a falsely increased creatinine result generated on the architect c8000 analyzer on a patient.Results provided: 15apr2022 sid (b)(4) (normal range: 0.6-1.3 mg/dl), lot# 09277un21.Serum sample: sn# (b)(4) = 2.9 / 2.9 mg/dl, sn# (b)(4) = 2.9 / 2.9 mg/dl, sn# (b)(4) = 2.8 mg/dl, sn# (b)(4) = 2.8 mg/dl.Previous result for this patient = 0.9 mg/dl.Mayo labs (roche platform) = 0.9 mg/dl 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 3l81-23).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 a plasma sample, drawn at the same time did not show the higher-than-expected results as did the serum sample.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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14358009
• Report Number: 3002809144-2022-00168
• Device Sequence Number: 4097976
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 05/25/2023
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 09277UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 C8 PROC MOD, 01G06-11, C803830, C803834; ARC C8 PROC MOD, 01G06-11, C803830, C803834
• Patient Sex: Unknown