FDA Adverse Event
Other
Summary report: N
ABL80 FLEX CO-OX ANALYZER
MDR report key: 2685395
·
Received July 31, 2012
Report
- Report Number
- 2027541-2012-00037
- Event Type
- Other
- Date Received
- July 31, 2012
- Report Date
- July 4, 2012
- Manufacturer
- SENDX MEDICAL, INC.
- Product Code
- CHL
- PMA / PMN Number
- K080370
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS THE DEFICIENCY EXPRESSED BY THE CUSTOMER RESEMBLES THAT OF A PREVIOUSLY REPORTED MDR, THIS EVENT WILL BE REPORTED AS AN MDR ACCORDING TO THE 2-YEAR ASSUMPTION RULE EVEN THOUGH NO EVIDENCE OF A MALFUNCTION COULD BE ESTABLISHED.
Description of Event or Problem · 1
A CUSTOMER REPORTED PO2 RESULTS FROM AN ABL80 CO-OX ANALYZER THAT WERE UP TO 20 MMHG LOWER THAN RESULTS FROM ANOTHER ANALYZER IN A CLINIC LABORATORY. THE SAMPLES WERE FROM ADULT PTS AND COLLECTED IN CAPILLARY TUBES. THE REPORTED RESULTS WERE NOT USED FOR ANY PT DIAGNOSIS OR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABL80 FLEX CO-OX ANALYZER | PH, BLOOD GAS, ELECTROLYTE ANALYSIS SYST | CHL | SENDX MEDICAL, INC. | 393-841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |