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

Catalog Number	08057800190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16491579
• Report Number: 1823260-2023-00691
• Device Sequence Number: 6758604
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/06/2023

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
• 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: 02/08/2023
• Initial Report FDA Received Date: 03/06/2023
• 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