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

Catalog Number 08057800190

Device Problem Non Reproducible Results (4029)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for an unspecified number of patient samples tested with gluc3 glucose hk gen.3 on a cobas pro c 503 analytical unit (serial number: (b)(4).Examples of data were provided for two patient samples.No questionable results were reported outside of the laboratory.The first patient sample initially resulted in a glucose value of 13 mg/dl and repeated as 115 mg/dl.A second affected patient sample was repeated as part of a precision test and the following glucose values were obtained: 92.7 mg/dl, 92.5 mg/dl, 92.5 mg/dl, 92.4 mg/dl, 92.7 mg/dl, 92.6 mg/dl, 92.5 mg/dl, 92.8 mg/dl, 92.7 mg/dl, 92.5 mg/dl, 92.5 mg/dl, 92.6 mg/dl, 92.4 mg/dl, 92.8 mg/dl, 13.9 mg/dl, 92.8 mg/dl, 92.8 mg/dl, 92.7 mg/dl.

Manufacturer Narrative

The field service engineer found a contaminated probe.The wash station water jet was also not strong enough and the customer did not clean it regularly.The engineer resolved the issues.No further issues occurred after the service actions were performed.The investigation determined the issue is consistent with incorrect pre-analytic sample handling and missing maintenance.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16491579
• MDR Text Key: 311531839
• Report Number: 1823260-2023-00691
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• 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