I-STAT CG8+ CARTRIDGE
Report
- Report Number
- 2245578-2022-00037
- Event Type
- Malfunction
- Date Received
- March 16, 2022
- Date of Event
- March 9, 2022
- Report Date
- April 5, 2022
- Manufacturer
- ABBOTT POINT OF CARE
- Product Code
- CHL
- UDI-DI
- 10054749000163
- PMA / PMN Number
- K940918
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 01-APR-2022. THROUGH INVESTIGATION OF A PREVIOUS CUSTOMER COMPLAINT (INCIDENT: 877194), A DEFICIENCY FOR ELEVATED RATE OF UNEXPECTED (HIGH) ICA RESULTS WHEN TESTING WITH CARTRIDGES FROM CG8+ LOT W21198 WAS IDENTIFIED. THIS ISSUE IS UNDER INVESTIGATION UNDER QUALITY RECORDS (QRS) (B)(4).
ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT IONIZED CALCIUM RESULTS OF 2.22 ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION. METHOD, DATE, TESTED RESULT: I-STAT (B)(6) 2022 17:31 2.22 MMOL/L, LAB (B)(6) 2022 17:40 1.46 MMOL/L. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.
NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779570 | I-STAT CG8+ CARTRIDGE | CG8+ CARTRIDGE | CHL | ABBOTT POINT OF CARE | NA | W21198 | 10054749000163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |