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

Model Number C502

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 317878837
• Report Number: 1823260-2023-02039
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1