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

Catalog Number	04404483190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for 4 patient samples tested with a particular reagent lot for gluc3 glucose hk (gluc3 ) on a cobas integra 400 plus.The results with reagent lot 625672 were higher than the repeat results with reagent lot 698268.Patient 1 initial result was 132.5 mg/dl.The repeat result was 84.8 mg/dl.Patient 2 initial result was 133.3 mg/dl.The repeat result was 89.9mg/dl.Patient 3 initial result was 132.5 mg/dl.The repeat result was 84.8 mg/dl.Patient 4 initial result was 153.7 mg/dl.The repeat result was 111.2 mg/dl.
Additional Manufacturer Narrative
The integra 400 plus serial number was (b)(6).The customer had no further issues after replacing the reagent pack.Calibration was acceptable.The qc data provided showed imprecision.Maintenance data indicate several maintenance actions are overdue.Several "clot detection" and "no fluid detection" alarms were observed on the alarm trace data.These alarms suggest pre-analytic issues.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration data was within specifications.Quality control data showed imprecision.Several maintenance actions were observed to be overdue.Upon review of the alarm trace, no fluid detected and clot detected alarms were observed.The investigation determined the issue is consistent with incorrect pre-analytic sample handling and missed customer maintenance.

• 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: 17363135
• Report Number: 1823260-2023-02376
• Device Sequence Number: 17665079
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/11/2023

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 04404483190
• Device Lot Number: 62567201
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/11/2023
• 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