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

Catalog Number 11896954176

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

The test strips were returned for investigation.The investigation confirmed there were no abnormalities with the returned test strips.The investigation performed a visual reading with the returned test strips with 0-native-urine, a nitrite-dilution-series, a leucocytes-dilution-series, and a protein-dilution-series.The investigation confirmed no discrepant results were observed.On a regular basis, combur 5-test hc 10 strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.Occupation is patient/consumer.

Event Description

The initial reporter received questionable protein and leukocyte results for one patient tested with urine combur 5-test hc 10 strips.On (b)(6) 2021, the patient had "increased" values for protein and leukocytes.On (b)(6) 2021, the patient was "at the doctor" and had their urine tested twice.For both tests, it was reported that there was "no discoloration." on (b)(6) 2021, the patient had an "increased" value for leukocytes.

• 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: 13561973
• MDR Text Key: 289517422
• Report Number: 1823260-2022-00426
• 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: 02/18/2022

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: Lay User/Patient
• Device Catalogue Number: 11896954176
• Device Lot Number: 56749701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/18/2022
• 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
• Treatment: UNSPECIFIED ANTIBIOTICS
• Patient Sex: Female