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

Catalog Number 03260763160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The retention material of lot 36897000 was measured on a cobas u411 and urisys 1800 with zero native urine and a nitrite dilution series and was visually checked.The measurements showed no false positive results and showed no abnormalities.The investigation is ongoing.

Event Description

The initial reporter complained of questionable negative nitrite results for an unspecified number of patient urine samples tested on a urisys 1100 analyzer serial number (b)(4).The customer provided an example.The nitrite result on the urisys 1100 was negative.The nitrite result with a visual reading was positive.The customer stated that since patients exhibited symptoms of urinary tract infection the physician requested urine cultures.An unspecified number of the patients were positive for urinary tract infections.The customer did not run qc.

Manufacturer Narrative

The customer's urisys 1100 analyzer was provided for investigation.The customer's urisys 1100 analyzer ux09661128 was measured with another strip lot (43065200) with native urine.The measurements showed no false negative results and showed no abnormalities.

• 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: 9221003
• MDR Text Key: 218993171
• Report Number: 1823260-2019-03825
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03260763160
• Device Lot Number: 36897002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1