MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 7 TEST; URINE TEST STRIPS

Catalog Number 11008552191

Device Problems False Negative Result (1225); Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The customer alleged false negative leukocyte results while using the combur 7 test strips.The customer tested the patient sample multiple times and always received a negative result.The patient was tested using another manufacturer test strip and the result was positive.This was the expected result based on the patient's symptoms and known condition.

Manufacturer Narrative

The retention material of lot 67817800 was tested by visual reading with native-urine and a leukocytes-dilution-series and the results were acceptable.The retention material showed no abnormal results and fulfilled the requirements.The test strips were requested from the customer for further investigation.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR 7 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: 18850827
• MDR Text Key: 337363207
• Report Number: 1823260-2024-00679
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11008552191
• Device Lot Number: 67817803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRUM MULTI VITAMINS
• Patient Sex: Female