CHEMSTRIP ® 10 MD
Received Jul 11, 2019 · Event occurred Jun 11, 2019
Report 1823260-2019-02534 · MDR key 8780585
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03260763160
Lot number
33828902
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DOES NOT RUN QC. THE CUSTOMER USED 3 VIALS OF TEST STRIPS WITH THE SAME LOT NUMBER. TWO VIALS HAVE BEEN DISCARDED. THE ONE REMAINING VIAL WAS REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR 5 PATIENTS TESTED WITH CHEMSTRIP 10 MD URINE STRIPS ON URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) ON (B)(6) 2019 AND (B)(6) 2019. WHEN THE METER RESULT WAS "POSITIVE" FOR ALL 5 PATIENTS, ALL 5 PATIENTS WERE GIVEN ANTIBIOTICS. NO SPECIFIC RESULTS WERE PROVIDED. A VISUAL READING WAS NOT PERFORMED. THE SAMPLES WERE SENT TO THE LABORATORY AND CULTURED. TWO DAYS AFTER THE METER RESULTS, THE CULTURE RETURNED AS NEGATIVE FOR NITRITES FOR ALL 5 PATIENTS. WHEN THE NEGATIVE RESULTS WERE RETURNED, THE ANTIBIOTICS WERE STOPPED. THE PHYSICIAN STATED NONE OF THE PATIENTS WERE ADVERSELY AFFECTED DUE TO THE ANTIBIOTICS. NO ADVERSE EVENT OCCURRED.
Additional Manufacturer Narrative
INVESTIGATION DID RETENTION TESTING ON ANOTHER LOT 33828900 AND ON THE CUSTOMER LOT. NO FALSE POSITIVE RESULTS WERE OBSERVED WITH METER OR STRIPS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.