MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-9-TEST 50STR.; URINE TEST STRIPS

Catalog Number 04510038191

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable results for two samples from one patient with the combur-9-test strips.On (b)(6) 2016, the patient had symptoms of urinary infection and was tested at the office of general practitioner (gp).The results for all parameters were negative.This sample was tested within one hour after collection.On (b)(6) 2016, another sample from the patient was tested at a gynecologist practice with combur 5 test strips lot 20603802 and positive results were received for leukocytes and nitrite.Specific results were not provided.On (b)(6) 2016, a third sample from the patient was tested at the gp office with combur 9 strips lot 10972702.The results for all parameters were negative.This sample was probably tested more than one hour after collection as the patient had collected the sample at home and went to the office on her own initiative.The patient was not adversely affected.At the gp office, the urine samples were not the first morning collection and were in plastic single-use containers.Information about the sample at the gynecologist was unknown.All of the test strips were read visually.The strips were requested to be returned for investigation.

Manufacturer Narrative

One vial of strips from lot 10972702 containing 16 test strips was received for investigation.The customer material and the retention material were visually tested with native urine and a nitrite and leukocyte dilution series.The reaction colors were in accordance to the standard label.No false negative reactions were observed.No other complaint has been received for this lot.A handling issue could not be totally excluded as a cause for the event.

• Brand Name: COMBUR-9-TEST 50STR.
• Type of Device: URINE TEST STRIPS
• 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: 6159197
• MDR Text Key: 62370323
• Report Number: 1823260-2016-01942
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04510038191
• Device Lot Number: 10972702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• 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