FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 6607442
·
Received June 2, 2017
Report
- Report Number
- 1056600-2017-00043
- Event Type
- Malfunction
- Date Received
- June 2, 2017
- Date of Event
- May 3, 2017
- Report Date
- June 2, 2017
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ORTHO CARE TSS CONFIRMED WITH THE CUSTOMER THAT ALL RED CELLS AND GEL CARDS HAVE ALL BEEN CONFIRMED TO HAVE NORMAL APPEARANCE AND HAVE BEEN STORED ACCORDING TO THEIR PACKAGE INSERT INDICATIONS. NO DISCREPANCIES WITH THE DAILY QC REPORTED BY THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED ORTHO CARE TO REPORT 2 SEPARATE EVENTS OF FALSE NEGATIVE RESULTS FOR TWO AB POSITIVE PATIENTS IN THE FORWARD PORTION OF THE MTS ABD/REV GEL CARD. NO INCORRECT RESULTS WERE REPORTED. INCIDENT 2 OF 2. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388041 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | MICROTYPING SYSTEMS | 3.2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |