MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 5-TEST HC 10 STR.; URINE TEST STRIPS

Catalog Number 11896954176

Device Problem High Test Results (2457)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

There was an allegation of questionable results with combur 5-test hc 10 urine strips.Prior to testing, the patient confirmed proper test strip storage.The patient performed a test and "found that after the measurement the glucose field was discolored dark green, although she had no symptoms." the patient checked the vial of remaining test strips for discoloration.The patient found the remaining test strips were discolored dark green for glucose.The patient confirmed the remaining test strips were ok for leukocytes.The patient performed a new test and the leukocyte field was negative.

Manufacturer Narrative

The strips were requested for investigation.Replacement product was sent.The patient sent the test strips for investigation.The investigation visually checked retention material of lot 49256400.The retention material of lot 49256400 showed no abnormalities.The investigation visually checked the returned test strips and all of the test strips showed discolorations.The investigation checked the returned vial for tightness and there were no abnormalities.The patient's test strips may not have been stored properly or the test strips may have been contaminated by liquid.The investigation did not identify a product problem.The specific cause of the event could not be determined.Initial reporter occupation is patient/consumer.

• Brand Name: COMBUR 5-TEST HC 10 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: 12786310
• MDR Text Key: 280599532
• Report Number: 1823260-2021-03309
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 11896954176
• Device Lot Number: 49256401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Date Manufacturer Received: 10/16/2021
• 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
• Patient Sex: Female