MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-10-M 100 STR; URINE TEST STRIPS

Model Number COMBUR-10-M

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.The retention material of lot 38908000 was visually checked and tested with a nitrite-dilution-series and 0-native-urine.The retention material showed no false positive results and fulfill the requirements.The investigation stated the test strip vial stopper contains a drying agent and was tested to be sufficient until all strips are used up if the user re-caps the vial right after removing a strip.There have been no other similar complaints received for this lot number.A 100% tightness check is performed on each vial prior to leaving the production line.The engineer at the customer site found that the test strip pusher was contaminated with urine.After cleaning the test strip pusher, negative qc results were back to normal and were negative.This suggests a handling issue at the customer site.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of positive nitrite results for "many" patient samples tested with combur-10 urine test strips.The customer alleged that the seal on the test strip vial was "not good" causing the positive nitrite results.The customer stated the samples were fresh, with no bacteria.Negative qc tests also showed as positive.

• Brand Name: COMBUR-10-M 100 STR
• 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: 8951347
• MDR Text Key: 203820211
• Report Number: 1823260-2019-03187
• Device Sequence Number: 1
• Product Code: JMT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMBUR-10-M
• Device Catalogue Number: 11379208173
• Device Lot Number: 38908002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• 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