FDA Adverse Event
Malfunction
Summary report: N
CHEMSTRIP® 10 UA
MDR report key: 2560219
·
Received May 4, 2012
Report
- Report Number
- 1823260-2012-02408
- Event Type
- Malfunction
- Date Received
- May 4, 2012
- Date of Event
- April 2, 2012
- Report Date
- May 24, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JIO
- PMA / PMN Number
- K896454
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE STRIPS WERE NOT RETURNED.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
THE USER RECEIVED QUESTIONABLE URINALYSIS RESULTS FOR ONE PATIENT SAMPLE FROM THE URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULT FOR LEUKOCYTES WAS DISCREPANT. THE INITIAL RESULT WAS "NEGATIVE" FOR LEUKOCYTES. THE RESULT FROM THE CRITERION II METER FOR LEUKOCYTES IS 100 WBC/UL. THE CALLER DID A MICROSCOPIC CONFIRMATORY TEST WHICH SHOWED 0-2 WBC/HPF FOR LEUKOCYTES. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CALLER DOES NOT HAVE ANY SPECIFIC PATIENT INFORMATION. NO ACTIONS WERE REPORTED TAKEN BASED ON EITHER TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHEMSTRIP® 10 UA | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | JIO | ROCHE DIAGNOSTICS | NA | 20835301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 069 YR |