MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 UA; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11895354160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The meter and test strip have been requested for return.The retention material of lot 38877000 was measured on an iu urisys 1800 / u411 analyzer /u411 with 0-native urine and a nitrite-dilution-series.The results of the measurements fulfill requirements.No false-positive results were observed.During internal testing, roche determined the limits of detection (lod) for protein, nitrite, leukocytes, and erythrocytes on the urisys 1100 urine analyzer with chemstrip® 5 ob, chemstrip 7, chemstrip 10 md, and chemstrip 10 ua test strips were higher than what is listed in their respective test strip method sheets.This can lead to false negative results on the urysis 1100 urine analyzer for the four affected parameters.Roche has provided customers with the following instructions and workarounds: chemstrip 5 ob and chemstrip 7 test strips should only be read visually.They can no longer be read on the urisys 1100 urine analyzer.Chemstrip 10 md or chemstrip 10 ua test strips can be used with the urisys 1100 urine analyzer; however, a negative result for any one of the four affected parameters (i.E., protein, nitrite, leukocytes, and erythrocytes) on the urisys 1100 urine analyzer must be repeated with a new test strip that is read visually.

Event Description

The customer complained of false-negative nitrite results for both controls and an unspecified number of patients urine samples from a urisys 1100 urine analyzer serial number (b)(4).The date of the event was an approximation.The customer stated that the results from the urisys would be negative but upon visual inspection, the results would be positive.The results in question were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The meter was returned for investigation.The returned meter was tested using retention strips.The measurements showed no abnormalities.The retention material fulfill our requirements.

• Brand Name: CHEMSTRIP ® 10 UA
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8768951
• MDR Text Key: 150547563
• Report Number: 1823260-2019-02449
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 11895354160
• Device Lot Number: 38877004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-09/12/18-006-C
• Patient Sequence Number: 1