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	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gluc3 glucose hk gen.3 results for 1 patient sample on a cobas 4000 c311 stand alone system.The initial glucose result was 120 mg/dl.The customer questioned the high result as it did not match the patient's previous result and was prompted to repeat the sample.The customer also changed the reagent pack prior to sample repetition.The sample was repeated and the result was 82 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The alarm trace did not contain a conspicuous event.Based on the calibration and qc data, a general reagent issue could be excluded.The issue was resolved by the customer changing the reagent pack.

• 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: 19166618
• Report Number: 1823260-2024-01251
• Device Sequence Number: 7382342
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• PMA/510(K) Number: K061048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 08/31/2024
• Device Catalogue Number: 04404483190
• Device Lot Number: 73288001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/23/2024
• 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