MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-27 for I-STAT CHEM8+ CARTRIDGE 03P91-25 manufactured by Abbott Point Of Care, Inc..
[2782650]
On (b)(6) 2012, abbott point of care was contacted by a customer regarding unexpected hemoglobin (hb) results on an i-stat chem8+ cartridge. Time: 1451, hb: 6. 5, hct: 19. Time: 1501, hb: 10. 2, hct: 30 same sample. Time: 1514, hb: 5. 1, hct: 15 same sample. Based on the information available, there were no injuries associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[10090281]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[10299035]
(b)(4). The investigation was completed on (b)(4) 2012. No deficiency was identified and the cartridges are functioning according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2245578-2012-00374 |
| MDR Report Key | 2678723 |
| Report Source | 05 |
| Date Received | 2012-07-27 |
| Date of Report | 2012-07-23 |
| Date of Event | 2012-07-23 |
| Date Mfgr Received | 2012-10-25 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSEPH KICEINA |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6094549494 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2H8V4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT CHEM8+ CARTRIDGE |
| Generic Name | CHEM8+ CARTRIDGE |
| Product Code | CDS |
| Date Received | 2012-07-27 |
| Model Number | NA |
| Catalog Number | 03P91-25 |
| Lot Number | J12056 |
| Device Expiration Date | 2012-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE, INC. |
| Manufacturer Address | PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-27 |