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

Catalog Number 04404483190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

The customer questioned low results for 1 patient tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module.The initial gluc3 result was 29 mg/dl with a data flag.This result was not reported outside of the laboratory as the customer was not sure if it was correct.At 6:42 a.M.The patient had a result from an accu-chek meter of 92 mg/dl.The original sample was repeated on the c501 module and the result was 27 mg/dl with a data flag.This result was reported outside of the laboratory as it was close to the initial result of 29 mg/dl with a data flag.The doctor questioned the result of 27 mg/dl with a data flag.The point of care staff decided to test the patient on the accu-chek meter.At 8:26 a.M.The patient had a result from the meter of 111 mg/dl.The results from the accu-chek meter were believed to be correct.The sample was repeated on a different c501 module for troubleshooting purposes and the result was 26 mg/dl with data flag.The customer repeated the sample one more time on the different c501 module and the result was 26 mg/dl with a data flag.These results were not reported outside of the laboratory.On (b)(6) 2018 a new sample was obtained and the result from the initial c501 module was 107 mg/dl.This result was believed to be correct and was reported outside of the laboratory.The patient is not showing any symptoms of hypoglycemia.The physician stated the patient has a very high white count that could affect the glucose results.The customer was not having any issues with other patients tested for gluc3.No adverse event occurred.The c501 module serial number was (b)(4).The customer declined a service visit.

Manufacturer Narrative

Calibration and qc were acceptable.The customer thinks the low results were due to the sample being drawn above an iv site.The customer believes the issue was resolved.They drew a new sample and obtained a correct result.

• 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: 7867923
• MDR Text Key: 119950640
• Report Number: 1823260-2018-03076
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 4015630920297
• Combination Product (y/n): N
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR