MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUCO-QUANT GLUCOSE/HK; "HEXOKINASE, GLUCOSE"

Catalog Number 11929534216

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned low results with pediatric samples tested for gluco-quant glucose/hk (glu) with reagent lots r1 reagent - (b)(4) and r2 reagent - (b)(4) on a modular p analyzer.These reagents have been in use since (b)(6) 2015.Data was provided for (b)(6) pediatric samples.Of the data provided, (b)(6) patient samples were erroneous.The samples were repeated with new reagent lots of r1 reagent - (b)(4) and r2 reagent - (b)(4) on a 2nd modular p analyzer.The customer thinks the results from the new reagent lots are correct.The initial low results did not fit the clinical picture for these patients.The erroneous results were reported outside of the laboratory.The corrected results were provided to the physician.It is not clear whether the repeat results were performed on the same day as the initial results or a week later.See the attachment to the medwatch for the patient results.No adverse event occurred.The modular p analyzer serial number was (b)(4).It was noted that the customer has had no issues since changing to the new reagent lots on (b)(6) 2015.It was also noted that the customer had no issue with adult samples tested for glu.The issue only occurred with pediatric samples.

• Brand Name: GLUCO-QUANT GLUCOSE/HK
• Type of Device: "HEXOKINASE, GLUCOSE"
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5261191
• MDR Text Key: 32510805
• Report Number: 1823260-2015-04659
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K812303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11929534216
• Device Lot Number: 607532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/16/2015
• 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