MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA GLUCOSE HK GEN. 3; HEXOKINASE, GLUCOSE

Model Number	C502
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The magnesium reagent lot number was 671588.The expiration date was not provided.The glucose reagent lot number was 698268.The expiration date was not provided.The customer performed the weekly maintenance and reran qc.Qc was acceptable.No further issues were reported afterward.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with a magnesium assay and with a glucose assay on a cobas 8000 cobas c502 module.Magnesium: initial result: 0.95 mg/dl rerun result: 1.6 mg/dl.Glucose: initial result : 37.1 mg/dl rerun result: 83.0 mg/dl.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
Sections d, d1, d2, d2b, d4, g1 and g4 were updated.The investigation did not identify a product problem.The cause of the event could not be determined.The issue was resolved by performing the weekly maintenance (cleaning cell covers, rinse stations, sample and reagent probes, nozzles, and running the weekly pipe including washing reaction parts).

• Brand Name: COBAS INTEGRA GLUCOSE HK GEN. 3
• 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: 17175367
• Report Number: 1823260-2023-02039
• Device Sequence Number: 3584652
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2024
• Device Model Number: C502
• Device Catalogue Number: 04404483190
• Device Lot Number: 69826801
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• 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