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 CELITE CARTRIDGE 03P86-25 manufactured by Abbott Point Of Care.
[90307190]
Apoc incident (b)(4). Apoc labeling was evaluated during the investigation as pertaining to the event. The investigation was completed on 11/08/2016. Retain product was not tested, as the lot expired prior to the investigation open date. Investigation: the device history record for this lot was reviewed. The lot passed finished goods release criteria. 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
[90307191]
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat act celite cartridges that yielded an unexpected result on a patient. There was no additional patient information available at the time of this report. Date: (b)(6)/2016, time: 13:17, actc result: 93. (b)(6)2016, 13:59, 102. The patient received 6000 units of heparin at 1306, and another 6000 units of heparin at 1320. 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 | 2245578-2017-00375 |
MDR Report Key | 6932318 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2017-10-09 |
Date of Report | 2017-10-09 |
Date of Event | 2016-07-06 |
Date Mfgr Received | 2017-09-13 |
Device Manufacturer Date | 2016-02-15 |
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 CELITE CARTRIDGE |
Generic Name | ACT CELITE CARTRIDGE |
Product Code | JBP |
Date Received | 2017-10-09 |
Model Number | NA |
Catalog Number | 03P86-25 |
Lot Number | R16046 |
Device Expiration Date | 2016-07-28 |
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 | 2017-10-09 |