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

Catalog Number 04404483190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant high results for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module.The customer was comparing results between the naf sample tube and the results from the lithium-heparin sample tube.The initial result from the naf tube 1162 mg/dl with a data flag.The sample was repeated and the result was 1715 mg/dl.The initial result from the lithium-heparin tube was 173 mg/dl.The result of 1715 mg/dl was reported outside of the laboratory.The naf tube was repeated with a result of 1061 mg/dl with a data flag.The sample was repeated with a result of 1645 mg/dl.On (b)(6) 2019 the lithium-heparin tube was repeated with a result of 141 mg/dl.The naf tube was repeated again with a result of 1134 mg/dl with a data flag.The sample was repeated with a result of 1663 mg/dl.On (b)(6) 2019 the lithium-heparin tube was repeated again with a result of 100 mg/dl.The naf tube was repeated again with a result of 1074 mg/dl with a data flag.The sample was repeated with a result of 1618 mg/dl with a data flag.There was no allegation that an adverse event occurred.The c501 module serial number was (b)(4).The customer was not having issues with other assays, calibration and qc were acceptable and instrument maintenance was up to date.

Manufacturer Narrative

Relevant tests laboratory data and other relevant history were updated.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8443309
• MDR Text Key: 139704182
• Report Number: 1823260-2019-01177
• 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,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04404483190
• Device Lot Number: 371182
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 MO