FDA Adverse Event
Malfunction
Summary report: N
ICHEM 100
MDR report key: 3748664
·
Received November 22, 2013
Report
- Report Number
- 2023446-2013-00001
- Event Type
- Malfunction
- Date Received
- November 22, 2013
- Date of Event
- August 7, 2013
- Report Date
- November 22, 2013
- Manufacturer
- IRIS INTERNATIONAL
- Product Code
- JJW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IRIS PRODUCT IFU INSERT STATES THAT THE DIAGNOSTIC OR THERAPEUTIC DECISIONS SHOULD NOT BE BASED ON ANY SINGLE RESULT OR METHOD. THEREFORE, DECISION OF CLINICIAN TO ADMINISTER THERAPY BASED ON SINGLE FALSE POSITIVE OR FALSE NEGATIVE RESULT IS INDICATIVE OF USES OF DEVICE OFF LABELED CLAIM. THE FOLLOWING MDR IS RELATED TO THIS EVENT, WHICH DOCUMENTS THE OTHER REAGENT LOT# GENERATED ON DIFFERENT DATE: 2023446-2013-00002.
Description of Event or Problem · 1
CUSTOMER REPORTED FALSE POSITIVE LEUKOCYTE ESTERASE RESULTED IN PTS RECEIVING UNNECESSARY ANTIBIOTIC PRESCRIBED BY PHYSICIANS. THE FALSE POSITIVE WAS CONFIRMED VIA URINE MICROSCOPY AND URINE CULTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610226 | ICHEM 100 | URINE CHEMISTRY STRIPS | JJW | IRIS INTERNATIONAL | 800-7005 | 510033A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |