MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-24 for I-STAT CHEM8+ CARTRIDGE 09P31-25 manufactured by Abbott Point Of Care.
[80906953]
(b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[80906954]
On (b)(6)2017, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges that yielded suspected discrepant hematocrit result on a patient presented with jaundice/ altered mental status and weakness. There was no patient information at the time of this report. The customer states that product is available for investigation. Method: sample: date: collection: test : result: i-stat, a-wb, (b)(6)2017, 1822, 1828, hct 38 / hb 12. 9. Beckman, b-wb, (b)(6)2017, 1822, 1828, hct 18. 7 / hb 5. 8. I-sta,t a-wb, (b)(6)2017, 1822, 1850, hct 24 / hb 8. 2. On (b)(6)2017 at 08:05, the patient received a blood transfusion of fresh frozen plasma , 1 unit each time based on the lab result. There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2017-00037 |
| MDR Report Key | 6736996 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-24 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2017-03-30 |
| Date Added to Maude | 2017-07-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA MACZUSZENKO |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6136885949 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2H 8V4 |
| 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 | GKF |
| Date Received | 2017-07-24 |
| Model Number | NA |
| Catalog Number | 09P31-25 |
| Lot Number | H17089B |
| Device Expiration Date | 2017-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Brand Name | I-STAT CHEM8+ CARTRIDGE |
| Generic Name | CHEM8+ CARTRIDGE |
| Product Code | JGS |
| Date Received | 2017-07-24 |
| Model Number | NA |
| Catalog Number | 09P31-25 |
| Lot Number | H17089B |
| Device Expiration Date | 2017-09-14 |
| 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 |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-24 |