CHEMSTRIP 7
Received Jun 13, 2022 · Event occurred Apr 27, 2022
Report 1823260-2022-01716 · MDR key 14676398
Device
Generic name
Urine Test Strip
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11008552160
Lot number
53644502
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- High Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THIS REPORT WAS INITIALLY PROVIDED TO ROCHE BY FDA VIA MEDWATCH (B)(4). ROCHE URINE DIPSTICK PRODUCTS ARE GIVING TRACE PROTEIN RESULTS ON A NORMAL QUALITY CONTROL. (EXPECTED RESULT IS NEGATIVE). CHEMSTRIP 7 (PRODUCT NUMBER (B)(4) ACROSS MULTIPLE LOT NUMBERS, LOCATIONS AND USERS. ALSO OBSERVED IN THE CHEMSTRIP 10, AND CHEMSTRIP 10SG PRODUCT. FDA SAFETY REPORT ID #:(B)(4).
Additional Manufacturer Narrative
THE CUSTOMER DROPPED THE QC SOLUTION ONTO THE TEST PADS, TIPPED THE STRIP ALLOWING THE EXCESS SOLUTION TO RUN OFF THE SIDES, AND THEN READ IT. THE RECOMMENDED TECHNIQUE IS TO DIP THE STRIPS INTO THE QC SOLUTION. THE RETENTION MATERIAL OF LOT 53644500, 55018600, AND 51951500 WERE INVESTIGATED AND MEASURED BY VISUAL READING. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.