MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 9 TEST; URINE TEST STRIPS

Catalog Number 04510046040

Device Problem False Negative Result (1225)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant negative results for 1 patient tested with the combur 9 test urine test strip.The bacteria result from the urine test strip was "negative." the sample was tested in the laboratory and the microbial count per milliliter was > 1,000,000.E.Coli bacteria were identified.

Manufacturer Narrative

The test strips were requested for investigation.The retention material of lot 64814300 was checked by visual reading with 0-native urine.The results of all measurements fulfill the requirements.No abnormal colors were observed.The investigation is ongoing.

Manufacturer Narrative

The customer did not return the test strips.The retention material of lot: 64814300 was checked by visual reading with 0-native urine, a nitrite dilution series, and a leukocytes dilution series.The results of all measurements fulfill the requirements.No false negative results were observed.As no product was returned, a specific root cause could not be determined.The investigation did not identify a product problem.

• Brand Name: COMBUR 9 TEST
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18661400
• MDR Text Key: 334790299
• Report Number: 1823260-2024-00362
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): Y
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 04510046040
• Device Lot Number: 64814302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• 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