• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS CHEMSTRIP ® 10 MD; URINE TEST STRIPS Back to Search Results
Catalog Number 03260763160
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer complained of false positive nitrite results for both a patient sample and qc material on the urisys 1100 urine analyzer with serial number (b)(4).The patient was tested on the analyzer at approximately 8:00 a.M.And the nitrite result was positive.A new test strip was dipped into the same urine sample and the visual result was negative.A third test strip was dipped in the sample and rerun through the analyzer and the results were negative.The patient sample was also tested by an unspecified laboratory method.The details and results of this test are not known.The positive result was not believed and no treatment decisions were made based off of the positive result.No adverse event occurred.The customer runs qc daily on the instrument.The instrument passed calibration on (b)(6) 2018.Qc results from (b)(6) 2018 were also positive for nitrite.The analyzer and test strips were requested for investigation.Retention material of lot #21650700 was measured on a urisys 1100 and was visually checked.The results of the measurements fulfill requirements.No false positive results were observed.
 
Manufacturer Narrative
The meter was returned.The test strips were not returned.The tray was dirty on the meter and the downholder piece was missing.Since the downholder piece was missing and the tray was dirty on the customer's returned meter, a tray from the investigation unit was used for testing the customer's meter.The retention material of lot 21650700 was measured on the customer's urisys 1100 and a urisys 1100 from the investigation unit with native urine, a nitrite-dilution-series, and was visually checked according to the testing plan.The results of the measurements fulfill the requirements.No false positive results were observed.Since the customer did not return the test strips, the investigation could not be completed.The investigation was unable to find a definitive root cause.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHEMSTRIP ® 10 MD
Type of Device
URINE TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key7276379
MDR Text Key100524656
Report Number1823260-2018-00474
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Medical Assistant
Type of Report Initial,Followup
Report Date 05/21/2018
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 Date06/30/2018
Device Catalogue Number03260763160
Device Lot Number21650703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2018
Initial Date FDA Received02/16/2018
Supplement Dates Manufacturer Received01/30/2018
Supplement Dates FDA Received05/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-