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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
A physician complained that architect creatinine results were too high.The samples were retested and the values were lower.The following examples were provided.Sid (b)(6): initial result 2.00 mg/dl, repeat result 1.44 mg/dl.Sid (b)(6): initial results 2.13 and 2.15 mg/dl, repeat results 1.59 and 1.60 mg/dl.Sid (b)(6): initial result 2.11 mg/dl, repeat result 1.52 mg/dl.Sid (b)(6): initial result 2.10 mg/dl, repeat result 1.50 mg/dl.Sid (b)(6): initial result 2.01 mg/dl, repeat result 1.45 mg/dl.Sid (b)(6): initial result 2.03 mg/dl, repeat result 1.48 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 60656un20.Trending review determined no adverse trend for elevated results for the product.Return testing was not completed as returns were not available.The issue appears to be sample specific for certain patient samples caused by pre-analytic and/or instrument errors.After troubleshooting, the issue was resolved and acceptable results were generated.Historical performance data also suggests the product is performing acceptably.Quality control results were within range at the time of the incident.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of creatinine reagent lot 60656un20 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: 12192819
• Report Number: 3002809144-2021-00433
• Device Sequence Number: 11612412
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/23/2021

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 Expiration Date: 05/16/2022
• Device Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Device Lot Number: 60656UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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 C8 PROC MOD, 01G06-11, C803904