FDA Adverse Event
Malfunction
Summary report: N
ADAMS/MIDAS PROTOCOL DISKETTE
MDR report key: 56189
·
Received December 12, 1996
Report
- Report Number
- 2250051-1996-00033
- Event Type
- Malfunction
- Date Received
- December 12, 1996
- Date of Event
- September 6, 1996
- Report Date
- December 5, 1996
- Manufacturer
- ORTHO DIAGNOSTIC SYSTEMS INC.
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE ARE DROPLETS AT THE END OF PIPETTE TIPS WHILE PIPETTING 50UL OF POSITIVE CONTROL DURING AN HIV-1 P24 ANTIGEN ASSAY. THE ROOT CAUSE HAS BEEN DETERMINED TO BE THE SOFTWARE. DEVICES VERSION 2.0. INVESTIGATION HAS SHOWN THAT THE SOFTWARE INSTRUCTS THE SAMPLE HANDLER TO DISPENSE THE INITIAL 50UL OF POSITIVE CONTROL AT AN INCORRECT HEIGHT. THIS CAUSES A DROPLET TO BE POSSIBLY LEFT ON THE END OF THE TIP. NO DEATH OR SERIOUS INJURY HAS BEEN ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAMS/MIDAS PROTOCOL DISKETTE | MEDICAL DEVICE SOFTWARE | JTC | ORTHO DIAGNOSTIC SYSTEMS INC. | NA | VERSION 2.0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |