MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 7 100 STR.; URINE TEST STRIPS

Catalog Number 11008552119

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of false negative visual reading results for approximately 10 patients tested for nitrites with chemstrip 7 test strips.It is not known what analyzer the customer is using.No other specific details were provided.It is not known what laboratory method the visual readings are being compared to.No patient specific information was provided related to medications that may be affecting the results.There was no allegation that an adverse event occurred.The test strips were requested for investigation.

Manufacturer Narrative

The customer returned the test strips.The dry test strips showed no abnormalities.The retention material of lot 27638200 and the customer material of lot 27638203 were both measured with 0-native urine a leucocyte-dilution-series, a erythrocytes-dilution-series and a nitrite-dilution-series.The retention material fulfills the requirements and meet specification.The nitrite parameter of the customer's test strips meet specification.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

How did the customer determined that the results were negative? answer: we have specific information related to one patient with test results showing negative for nitrites.A patient¿s results showed a trace of leukocytes and blood and were negative to nitrites.This patient was very symptomatic so the physician started her on an antibiotic and sent the urine to the lab.The lab results showed the patient had large leukocytes and blood and was also positive for nitrites.A urine culture later showed the presence of bacteria.Were the false negative results reported to the physician, and were all of the 10 patients diagnosed with a urinary tract infection later on? answer: the results were generated in the physician¿s office and read by the physician.We do know that one patient¿s results showed a trace of leukocytes and blood and were negative to nitrites.This patient was very symptomatic so the physician started her on an antibiotic and sent the urine to the lab.The lab results showed the patient had large leukocytes and blood and was also positive for nitrites.A urine culture later showed the presence of bacteria.The customer stated that not all the false negative nitrite patients were later diagnosed with uti, only a few of the patients were.During the investigation it was observed that the test pads show green dots.It is most likely that splash contamination from a cleaning reagents like peroxidase with appropriate chemical properties is the cause of this issue.The customer is no longer experiencing the issue.

• Brand Name: CHEMSTRIP 7 100 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8216559
• MDR Text Key: 132088045
• Report Number: 1823260-2019-00037
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: 11008552119
• Device Lot Number: 27638203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1