FDA Adverse Event
Malfunction
Summary report: N
LEADCARE II ANALYZER
MDR report key: 7141959
·
Received December 22, 2017
Report
- Report Number
- 1218996-2017-00010
- Event Type
- Malfunction
- Date Received
- December 22, 2017
- Date of Event
- February 13, 2017
- Report Date
- December 22, 2017
- Manufacturer
- MAGELLAN DIAGNOSTICS
- Product Code
- DOF
- UDI-DI
- 00850355006017
- PMA / PMN Number
- K052549
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE FAILURE OF THE LEADCARE II, HOWEVER BATTERIES RUPTURED. CAUSE FOR RUPTURED BATTERIES COULD NOT BE DETERMINED. EVIDENCE OF BATTERY CORROSION ON RIGHT SIDE BATTERY COMPARTMENT. ANALYZER WAS ABLE TO BE POWERED ON. NO INDICATION OF INJURY OR HARM TO THE USER. LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S (B)(4) ISSUED ON 29JUN2017.
Description of Event or Problem · 1
BATTERIES RUPTURED AND LEAKED BATTERY ACID WHEN INSERTED INTO THE INSTRUMENT FOR THE FIRST TIME. NO INJURY OR OTHER PROBLEMS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922892 | LEADCARE II ANALYZER | LEADCARE II | DOF | MAGELLAN DIAGNOSTICS | 00850355006017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |