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

Model Number COMBUR 9

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.There were no follow up actions for the event.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Questionable high results were generated by the combur 9 test strips.The events involved an unspecified number of patients tested for nitrites.The patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.The patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

Manufacturer Narrative

The investigation for the event is still ongoing.Follow up actions include: the customer material of lot 38054701 was provided for investigation.The retention material of lot 38054700 and the customer material of lot 38054701 were visually checked.The retention material showed no discolorations or abnormalities.The customer material shows discolorations on the nitrite, protein , ketone , urobilinogen, and bilirubin test pads.The customer's test strip vial was checked for tightness and this check passed.

Manufacturer Narrative

For the event, the investigation did not identify a product problem.The cause of the event could not be determined.The customer returned strip lot 38054701.The retention material of lot 38054700 and the customer material of lot 38054701 were visually checked.The customer vial was also tested for tightness.The retention material shows no discolorations or abnormalities.The customer material showed discolorations on the nitrite test pad.The test for tightness was passed.

• Brand Name: COMBUR-9-TEST 50STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9615419
• MDR Text Key: 219780542
• Report Number: 1823260-2020-90013
• Device Sequence Number: 1
• Product Code: JMT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: COMBUR 9
• Device Lot Number: 38054701
• Patient Sequence Number: 1