MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUCOSE HK; HEXOKINASE, GLUCOSE

Catalog Number	04657527190
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	05/09/2024
Type of Reportable Event	Malfunction
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 field service engineer (fse) performed a transfer head fluid sensor check, cleaned the water container, performed a fluid system prime, and checked the probe washing functions.The fse also observed that the sample tubes used by the customer had gel that was not consistent and stuck to the inner tube walls.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gluc3 glucose hk gen.3 results for 1 patient sample on a cobas c 111 analyzer.The initial glucose result of 536.54 mg/dl.The sample was repeated twice and the results were 273.71 mg/dl and 272.79 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: GLUCOSE HK
• 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: 19486657
• Report Number: 1823260-2024-01697
• Device Sequence Number: 20814358
• Product Code: CFR
• UDI-Device Identifier: 04015630922338
• UDI-Public: 04015630922338
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• PMA/510(K) Number: K071211
• 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): 07/02/2024

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: 04657527190
• Device Lot Number: 756035
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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