FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 3983618
·
Received August 6, 2014
Report
- Report Number
- 1056600-2014-00043
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 3, 2014
- Report Date
- August 6, 2014
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2014, AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE TO CHECK CAMERA ALIGNMENT. FE PERFORMED CAMERA ALIGNMENT AND OPTICS ADJUSTMENT AND DID NEW REFERENCE READ. CUSTOMER ACCEPTED CONTROLS AND DUAL POPULATION SAMPLES. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.
Description of Event or Problem · 1
CUSTOMER REPORTS PATIENT SAMPLES THAT CLEARLY SHOWED DUAL POPULATION OF CELLS IN THE ANTI-D MICROWELL WERE CALLED 4+ BY THE PROVUE AND WERE NOT FLAGGED AS "DP" AS EXPECTED. CUSTOMER REPORTED TWO INCIDENTS ON THIS INSTRUMENT. FIRST INCIDENT, PATIENT SAMPLE WAS TESTED ON (B)(6) 2014. THIS IS 2 OF 2. COMPLAINT: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461549 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | MICROTYPING SYSTEMS | 3.2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |