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

Catalog Number 08057800190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 290082643
• Report Number: 1823260-2022-01182
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057800190
• Device Lot Number: ASKU, 614042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1