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

Model Number COMBUR 9

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation, however, the customer declined to return the test strips.The retention material of lot 52422100 were visually tested with erythrocytes and leucocytes-dilution-series and 0-native-urine.The retention material fulfill the requirements.No abnormalities were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of questionable results for 1 patient tested with combur-9-test urine test strips.For the leukocytes and erythrocytes parameters, the results were "not indicated" but the results from the hospital were "pathological." the specific results were not provided.The customer declined to provide any additional information.

Manufacturer Narrative

The test strips were returned.The material showed no signs of damage or abnormalities.The customer's material of lot 52422101 was checked by visual function with an erythrocytes-dilution-series, an leucocytes-dilution-series and 0-native-urine.The customer's material fulfill the requirements.No abnormalities were observed.

• 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: 12778042
• MDR Text Key: 280527060
• Report Number: 1823260-2021-03284
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Model Number: COMBUR 9
• Device Catalogue Number: 04510038191
• Device Lot Number: 52422101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 12/14/2021
• 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