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

Catalog Number	08057800190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation reviewed the calibration data provided from 22-aug-2023 to 19-jul-2024; the results were within specifications.The investigation reviewed the qc level 2 recovery from (b)(6) 2024; the recovery was within the +/- 2 standard deviation range.The investigation ruled out a general reagent problem because the calibration and qc are acceptable, the investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable gluc3 glucose hk gen.3 result from one patient sample tested on the cobras c 503 analytical unit.The initial result was not reported outside of the laboratory.The reporter did not believe the initial result prompting the rerun of the patient sample.On (b)(6) 2024: the initial result from the analyzer's line 1 was 104 mg/dl.On (b)(6) 2024: the first repeat result from the analyzer's line 1 was 79.0 mg/dl.The second repeat result from the analyzer's line 3 was 81.3 mg/dl.The third repeat result from the analyzer's line 1 was 45.5 mg/dl with an invalidating data flag.
Additional Manufacturer Narrative
The investigation did not identify a product problem.
Additional Manufacturer Narrative
The investigation determined the event was consistent with a preanalytic issue at the customer site (poor sample quality).Preanalytics are within the customer's responsibility.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20007881
• Report Number: 1823260-2024-02405
• Device Sequence Number: 7164058
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 09/26/2024

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: 779013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 09/05/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/25/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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