MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-04 for I-STAT ACT KAOLIN CARTRIDGE 03P87-25 manufactured by Abbott Point Of Care.
[143978870]
(b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[143978873]
On (b)(6) 2019, abbott point of care was contacted by a customer regarding act kaolin cartridges that yielded unexpected results on a (b)(6) female patient with factor 12 deficiency. There was no patient information available at the time of this report. Return product is available for investigation. (b)(6). There are no injuries associated with this event. At this time there is no reason to suspect a malfunction exists. There were no baseline tests performed. There is no explanation for the two i-stat results of <50 which are incompatible with life, then >1000 on the repeat test. The results of <50 are suspected to be analytical errors but could not be confirmed. The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2019-00079 |
| MDR Report Key | 8484732 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-04 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2019-01-09 |
| Date Added to Maude | 2019-04-04 |
| 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 | 2019-04-04 |
| Returned To Mfg | 2019-03-20 |
| Model Number | NA |
| Catalog Number | 03P87-25 |
| Lot Number | R19009 |
| Device Expiration Date | 2019-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-04 |