FDA Adverse Event
Other
Summary report: N
ABL80 FLEX ANALYZER
MDR report key: 2685367
·
Received July 31, 2012
Report
- Report Number
- 2027541-2012-00038
- Event Type
- Other
- Date Received
- July 31, 2012
- Report Date
- July 10, 2012
- Manufacturer
- SENDX MEDICAL, INC.
- Product Code
- CHL
- PMA / PMN Number
- K051804
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
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 THAT AN ABL80 FLEX ANALYZER IN THE HOSPITAL'S RESPIRATORY DEPARTMENT GENERATED PO2 RESULTS THAT WERE MORE THAN 2.5 KPA DIFFERENT THAN OTHER ANALYZERS. THE PATIENT SAMPLES WERE ARTERIAL BLOOD COLLECTED IN CAPILLARY TUBES. THE CUSTOMER EXPRESSED CONCERN THAT PATIENTS WERE UNNECESSARILY BEING ADDED TO HOME O2 SERVICE BASED ON THESE PO2 RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABL80 FLEX ANALYZER | PH, BLOOD GAS, ELECTROLYTE ANALYSIS SYST | CHL | SENDX MEDICAL, INC. | 393-839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |