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

Catalog Number	04404483190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas integra 400 plus is (b)(6).The provided calibration data was ok.Quality controls were ok on the day of the event.A general reagent issue can be ruled out as calibration and quality controls are acceptable.Upon review of the alarm trace from on (b)(6) 2023 to on (b)(6) 2024, there are frequent clot detection alarms.There were also frequent alarms indicating "service cannot be started" and inadequate fluid.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with cobas integra glucose hk gen.3 on a cobas integra 400 plus.The sample initially resulted in a glucose value of 187.1 mg/dl.The clinician questioned the result since the patient did not have diabetes.The sample was repeated, resulting in a glucose value of 94.4 mg/dl.The repeat value was deemed correct and was reported outside of the laboratory.
Additional Manufacturer Narrative
It was determined that the laboratory temperature had a high variability during the day, which could impact tube storage conditions.The inadequate fluid errors can be an indicator of overfilled tubes or incorrectly configured tube settings on the analyzer.The clot alarms are indicative of a general pre-analytic sample handling issue.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• 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: 18615712
• Report Number: 1823260-2024-00285
• Device Sequence Number: 14063787
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• 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): 02/20/2024

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: 11/30/2024
• Device Catalogue Number: 04404483190
• Device Lot Number: 74348401
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/20/2024
• 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