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

Model Number CHEMSTRIP 10

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's test strips have been requested for investigation.The product has not been received at this time.Occupation is lay user/patient.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation is ongoing.

Event Description

The initial reporter received questionable nitrite and glucose results using chemstrip 10 urine test strips compared to a laboratory result using an unknown method.The test strips showed a false positive result with a visual reading.The patient questioned the result from the test strips and consulted a doctor.The laboratory results were negative.The laboratory result was believed to be correct.

Manufacturer Narrative

Sections d10 and h3 were updated.The customer's strips were returned for investigation.The customer's test strips were visually checked and the strips showed signs of discoloration.Discoloration of test strips is indicative of the vial being left open too long.The retention material of lot 41518000 was checked by visual reading with a nitrite-dilution-series, a glucose-dilution-series and 0-native-urine.The results of the measurements of the retention material meet specifications.No false positive results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10239506
• MDR Text Key: 198560521
• Report Number: 1823260-2020-01611
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CHEMSTRIP 10
• Device Catalogue Number: 11203479119
• Device Lot Number: 41518003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1