MAUDE Adverse Event Report: ABBOTT GMBH CLINICAL CHEMISTRY GLUCOSE

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2020
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.Patient information: patient identifier: the complete patient sid (b)(6).This was all the patient information provided.
Event or Problem Description
The customer reported a false elevated glucose result on the architect c8000 processing module for a patient.The following data was provided: on (b)(6) 2020 sid (b)(6) = initial result = 589 mg/dl, repeat result = 593 mg/dl (same analyzer), repeat result = 593 mg/dl (another architect analyzer), on (b)(6) 2020 repeat result = 535 mg/dl (radiometer-blood gas analyzer).On (b)(6) 2020 new sample was collected and generated a result of 82 mg/dl and repeat result of 84 (blood gas analyzer).There was no impact to patient management reported.
Additional Manufacturer Narrative
A review of the ticket determined that there is normal complaint activity for reagent lot 55727uq08.The trending review data determined no trends identified for the issue.Return testing was not completed as returns were not available.Data was provided for the patient sample where the sample was retested on the same instrument, a different c8000 system, and a radiometer analyzer gave similar elevated results.Quality control (qc) was in range.The cbc sample for this patient also gave questionable results.A new sample from the patient gave lower results for the assay.A review of the manufacturing documentation did not identify any issues associated with the complaint.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect glucose reagent lot 55727uq08.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10335247
• Report Number: 3002809144-2020-00752
• Device Sequence Number: 3623862
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 03L82-22
• Device Lot Number: 55727UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: ARCHITECT C8000 PROCESSING MODULE,; ARCHITECT C8000 PROCESSING MODULE,; CREATININE, LIST 03L81-22, LOT 33550UN20; CREATININE, LIST 03L81-22, LOT 33550UN20; LIST 01G06-11, SERIAL (B)(6); LIST 01G06-11,SERIAL (B)(6)