MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3; HEXOKINASE, GLUCOSE

Catalog Number	05168791190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter complained of questionable gluc hk gen.3 (glucose) results for multiple patients run on a cobas 8000 c7012 analyzer with (b)(4).The initial reporter provided results for 2 samples.For sample 1 the initial glucose was 11 mg/dl with a repeat of 95 mg/dl.Sample 2 had an initial glucose of 23 mg/dl with a repeat of 102 mg/dl.Sample 2 was rerun in the same primary tube without examination or recentrifugation.The initial reporter stated the issue is recurrent but random.She also said that the samples are stored at room temperature, 26-31c, and that fibrin has been observed in some sample tubes.She noted that a water hose from the osmosis unit was contaminated.No incorrect results were reported outside the laboratory.
Additional Manufacturer Narrative
The customer's calibration and qc were acceptable.A photometer check was inconspicuous.The alarm trace from the analyzer demonstrated multiple alarms for insufficient sample and abnormal aspiration on the date of the event.The facts that fibrin debris was observed in some sample tubes and that multiple abnormal aspiration alarms were received are consistent with a preanalytical issue.

• Brand Name: GLUC3
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16709758
• Report Number: 1823260-2023-01201
• Device Sequence Number: 6111476
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K061048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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 Catalogue Number: 05168791190
• Device Lot Number: 674271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown