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

Catalog Number	08057800190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with gluc3 glucose hk gen.3 on two cobas pro c503 modules.The sample initially resulted in a glucose value of 3.68 mmol/l on the first c503 system (serial number (b)(4)) and this vale was reported outside of the laboratory to the clinician.The clinician asked for a new sample to be collected from the patient and tested as the result was not consistent with the patient's clinical status and the patient had a capillary glucose result of 1.2 mmol/l.The sample was repeated on a second c503 analyzer (serial number unknown) and the result was identical to the first value.A second sample collected from the patient resulted in a glucose value of 1.0 mmol/l when tested on the first c503 system.A new capillary sample collected from the patient resulted in a glucose value of 1.1 mmol/l.The complained sample was later repeated on the first c503 system on (b)(6) 2022, resulting in a glucose value of 3.99 mmol/l.The glucose reagent lot number and expiration date used for the first measurement were requested, but not provided.The second measurement of the sample performed on (b)(6) 2022 was tested using glucose reagent lot 614042.The reagent expiration date was requested, but not provided.
Additional Manufacturer Narrative
Quality control data from february 2022 to april 2022 was provided and was within specifications.A general reagent issue can be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: GLUCOSE HK GEN.3
• Common Device Name: GLUCOSE HEXOKINASE
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14208533
• Report Number: 1823260-2022-01182
• Device Sequence Number: 16595260
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191899
• 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): 06/29/2022

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: 08057800190
• Device Lot Number: ASKU, 614042
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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