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

Catalog Number 03260763160

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s test strips and meter were requested for return.The customer's test strips were discarded and are not available for an investigation.The customer's meter was returned for an investigation.The customer confirmed the test strips were not discolored before use, the test strip position in the test strip tray was correct, the analyzer had a valid calibration within the last 7 days, and qc was performed and had passing results.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 complained of discrepant leukocyte and erythrocyte results for one patient tested with a urisys 1100 analyzer serial number (b)(4) compared to an unknown laboratory methodology.The patient¿s urine sample was first tested on the urisys analyzer at 1:54 p.M., and the same sample was sent to the laboratory for testing and urine culture at 2:00 p.M.(b)(6) 2020, the patient¿s urisys leukocyte and erythrocyte results were negative.The patient¿s laboratory leukocyte result was "+++," and the patient¿s laboratory erythrocyte result was "+.".

Manufacturer Narrative

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

• Brand Name: CHEMSTRIP 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10739444
• MDR Text Key: 213191956
• Report Number: 1823260-2020-02659
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 03260763160
• Device Lot Number: 42220105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACTRIM; INHALER; BACTRIM; INHALER
• Patient Age: 22 YR
• Patient Weight: 77