MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-09 for I-STAT ACT KAOLIN CARTRIDGE 03P87-25 manufactured by Abbott Point Of Care.
[90313535]
Apoc incident # (b)(4). Apoc labeling was evaluated during the investigation as pertaining to the event. The investigation was completed on 11/09/2015. Retain and return product was tested and found to be functioning according to specification. Investigation: the device history record for this lot was reviewed. The lot passed finished goods release criteria. Forty retained and twenty-two returned cartridges were tested using blood samples which simulate patients undergoing oral anticoagulant therapy. Testing met the acceptance criteria found in q04. 01. 003 rev. W, appendix 1 - product complaint level 2 and level 3 investigation procedure. No deficiency has been identified. Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.
Patient Sequence No: 1, Text Type: N, H10
[90313536]
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat act kaolin cartridges that yielded unexpected results on a patient. There was no additional patient information available at the time of this report. Actk results: >1000 (initial test). >1000 (retest 1). 602 (retest 2). At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2017-00373 |
| MDR Report Key | 6932306 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2015-05-04 |
| Date Added to Maude | 2017-10-09 |
| 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 | 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 ACT KAOLIN CARTRIDGE |
| Generic Name | ACT KAOLIN CARTRIDGE |
| Product Code | JBP |
| Date Received | 2017-10-09 |
| Returned To Mfg | 2015-10-05 |
| Model Number | NA |
| Catalog Number | 03P87-25 |
| Lot Number | T15124 |
| Device Expiration Date | 2015-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-09 |