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

Catalog Number	04404483190
Medical Device Problem Codes	No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gluc3 reagent lot number was 77896201 with an expiration date of (b)(6) 2025.The customer verbally stated that calibration and qc were in range.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 6 patients' samples tested with gluc hk gen.3 (gluc3) assay on a cobas 6000 c501 (ul) v analyzer.Discrepant results for 1 patient plasma sample were provided as an example.Initial result: 93 mg/dl.Validating the analyzer after a service visit prompted the repeat of the sample.On (b)(6) 2024: repeat result: 60 mg/dl.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, g1 and g4 were updated.The calibration was performed on (b)(6) 2024 and it was acceptable.During the service visit, the field service engineer noted that the specimen glucose stabilities were exceeded.He educated the customer regarding glucose stability with lithium heparin plasma specimens.The customer will use fresher <4 hr old specimens when performing patient comparisons.No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event was due to the exceeded specimen glucose stabilities.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20346731
• Report Number: 1823260-2024-02836
• Device Sequence Number: 8055236
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 10/24/2024

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: 04/30/2025
• Device Catalogue Number: 04404483190
• Device Lot Number: 77896201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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