MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-10 for I-STAT ACT KAOLIN CARTRIDGE 03P87-25 manufactured by Abbott Point Of Care.
[90191559]
(b)(4). Apoc labeling was evaluated during the investigation as pertaining to the event. The investigation was completed on 12/01/2016. Retain 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 cartridges were tested using whole blood as well as blood samples which simulate patients undergoing oral anticoagulant therapy. Testing met the acceptance criteria found in q04. 01. 003 rev. Z, 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
[90191560]
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat act kaolin cartridges that yielded unexpected results on a (b)(6) male patient. There was no additional patient information available at the time of this report. No date of testing was given by the customer, and the cartridge lot in use had expired when the complaint was reported; therefore, the date given in b3 is the date of expiration for the cartridge lot because the field cannot be left blank. (b)(6). 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 | 2245578-2017-00381 |
| MDR Report Key | 6938587 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2016-03-21 |
| Date Added to Maude | 2017-10-10 |
| 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 | 2017-10-10 |
| Model Number | NA |
| Catalog Number | 03P87-25 |
| Lot Number | R16080 |
| Device Expiration Date | 2016-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-10 |