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

Catalog Number 04404483190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter discarded the affected reagent pack out of precaution and installed a new pack.Quality controls recovered acceptably.The investigation determined the issue was resolved by the re-calibration performed by the reporter.

Event Description

On (b)(6) 2019, the initial reporter stated that quality controls were outside of range for gluc3 glucose hk gen.3 on the cobas 6000 c (501) module.The reporter re-calibrated using fresh calibrator material and controls were in range.The reporter then pulled 10 patient samples that had been tested on (b)(6) 2019 and repeated these.Of the ten samples, one had a discrepant glucose result.The incorrect value was reported outside of the laboratory.The sample initially resulted with a glucose value of 92 mg/dl and when repeated on (b)(6) 2019, it resulted with a value of 64 mg/dl.No adverse events were alleged to have occurred with the patient.

• Brand Name: GLUC3 GLUCOSE HK GEN.3
• Type of Device: HEXOKINASE, GLUCOSE
• 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: 8784222
• MDR Text Key: 150872290
• Report Number: 1823260-2019-02560
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 04404483190
• Device Lot Number: 39105101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1