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	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable glucose hk gen.3 results for one patient tested on a cobas c 503 analytical unit serial number (b)(4).The patient had two urine samples tested for glucose.The patient's questionable glucose results were reported outside the laboratory.The customer performed repeat testing with both samples.The "biologist discussed about these curious increasing glucose results from urine of this patient with his physician." the patient's first sample had an initial glucose result of "around 1000" mg/dl."around one hour later," the patient's first repeat glucose result was "around 2000" mg/dl.The first sample was tested "later" and the patient's second repeat glucose result was "around 2500" mg/dl.The patient's second sample had an initial glucose result of "around 800" mg/dl.The patient's repeat glucose result "later" was "around 1200 mg/dl.".
Additional Manufacturer Narrative
The customer's calibration and qc results, sample reaction monitors, and system alarm trace were requested but not provided.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 12575930
• Report Number: 1823260-2021-02906
• Device Sequence Number: 17121841
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/12/2021

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: 02/28/2022
• Device Catalogue Number: 08057800190
• Device Lot Number: 51902501
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DIABETES MEDICATION; UNSPECIFIED DIABETES MEDICATION
• Patient Sex: Unknown