MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 URINE TEST STRIPS

Model Number CHEMSTRIP 10

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.This event occurred in (b)(6).

Event Description

The initial reporter stated they received false negative nitrite results for an unspecified number of patient samples tested with chemstrip 10 test strips.These patients had urinary tract infections, but the test strip results did not indicate as such.The reporter mentioned that in (b)(6) 2020, they had three patients who went to the hospital and found out they had urinary tract infections after having been tested at the customer site with the affected test strips during the same week.

Manufacturer Narrative

The retention material of lot 368974 was checked by visual reading with native urine, a specific gravity dilution series, a leukocytes dilution series, a ph value dilution series, a nitrite dilution series, a protein dilution series, a glucose dilution series, a ketone dilution series, a urobilinogen dilution series, a bilirubin dilution series, and an erythrocytes dilution series were tested.No false negative or abnormal results received.The retention material showed no abnormalities and fulfilled requirements.

• Brand Name: CHEMSTRIP 10 URINE TEST STRIPS
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10091553
• MDR Text Key: 203668417
• Report Number: 1823260-2020-01303
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K896454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: CHEMSTRIP 10
• Device Catalogue Number: 11203479119
• Device Lot Number: 36897401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1