MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3 GLUCOSE HK GEN.3; HEXOKINASE, GLUCOSE

Catalog Number 05168791190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer stated calibration and qc were acceptable.

Event Description

The initial reporter complained of low results not corresponding to the clinical picture for 1 patient tested for gluc3 glucose hk gen.3 (gluc3) on a cobas 8000 c 702 module.The initial result from the c702 module was 0.61 mmol/l.The sample was repeated on the c702 module and the result was 0.58 mmol/l.These results were reported outside of the laboratory and questioned as the patient was not hypoglycemic.The patient was tested by capillary test on an unspecified point of care device and the result was within the reference range of 3.9 - 6.1 mmol/l.The specific result was not provided.The c702 module serial number was (b)(4).

Manufacturer Narrative

The investigation determined the issue was consistent with a pre-anlaytical handling issue at the customer site.Stability of glucose samples is affected by storage temperature, bacterial contamination and glycolysis.Plasma or serum samples without a preservative (naf) should be separated from the cells or clot within half an hour of being drawn.When blood is drawn and permitted to stand uncentrifuged at room temperature, the glucose result will decrease due to glycolysis.Glycolysis can be inhibited by collecting the sample in fluoride tubes.A product problem was not found.

• Brand Name: GLUC3 GLUCOSE HK GEN.3
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10142311
• MDR Text Key: 194767344
• Report Number: 1823260-2020-01416
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168791190
• Device Lot Number: 430760
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1