MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10 TEST; BLOOD, OCCULT, COLORIMETRIC, IN URINE

Catalog Number 04510062171

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

The customer complained of false negative erythrocytes (ery) results for an unknown number of patients when tested with "study" combur-10 urine test strips.The customer is comparing the combur-10 urine strips to siemens multistix which are tested on the siemens clinitek 50 instrument.The actual results have not been provided.This information has been requested.The date of event is not known.It is not known if the results are being used for diagnostic purposes.This information has been requested.It is not known if erroneous results were reported outside of the laboratory.It is not known if an adverse event occurred.No adverse event was reported.While the combur-10 urine strips are not sold in the us, the roche urine chemstrip is similar.Retention samples of the same lot that the customer used were tested.The reaction colors were acceptable and did not show any abnormalities.No false negative results were observed.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

All test strip specifications have been met for the retention samples tested.The customer has not made any further complaints about the strip lot used.

• Brand Name: COMBUR 10 TEST
• Type of Device: BLOOD, OCCULT, COLORIMETRIC, IN URINE
• 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: 4943173
• MDR Text Key: 6033600
• Report Number: 1823260-2015-03866
• Device Sequence Number: 1
• Product Code: JIO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04510062171
• Device Lot Number: 22933001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/02/2015
• 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
• Patient Sequence Number: 1