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

Catalog Number	04404483190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The integra 400 plus analyzer serial number was (b)(6).
Event or Problem Description
There was an allegation of discrepant results for 3 patient samples tested for cobas integra glucose hk gen.3 on a cobas integra 400 plus analyzer.Patient 1 initial result was 19 mg/dl.Since the result was low, the sample was repeated twice with results of 109 mg/dl.On (b)(6)2024 patient 2 initial result was 4.0 mg/dl.The repeat result was 86 mg/dl.On (b)(6)2024 patient 3 initial result was 1.0 mg/dl.The repeat result was 86 mg/dl.
Additional Manufacturer Narrative
The customer has not provided any additional information for the investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 19820347
• Report Number: 1823260-2024-02148
• Device Sequence Number: 12932589
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 10/04/2024

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 Catalogue Number: 04404483190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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