MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for I-STAT CK-MB CARTRIDGE 03P92-25 manufactured by Abbott Point Of Care.
[34815374]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34815375]
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat ck-mb cartridges that yielded suspected discrepant results on a (b)(6) male patient with cancer. There was no additional patient information at the time of this report. The customer states that return product is available for investigation. Method:i-stat, time:1545, ck-mb: 40. 4, sample: a. I-stat, 1730, 0. 4, a; i-stat, 2212, 0. 2, b. There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
[38254207]
Apoc incident # (b)(4). The investigation was completed on 02/04/2016. Customer returns and retain product was tested and are functioning according to specification..
Patient Sequence No: 1, Text Type: N, H10
[38254208]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2015-00071 |
| MDR Report Key | 5318887 |
| Date Received | 2015-12-22 |
| Date of Report | 2016-02-12 |
| Date of Event | 2015-12-19 |
| Date Mfgr Received | 2016-02-04 |
| Device Manufacturer Date | 2015-08-30 |
| Date Added to Maude | 2015-12-22 |
| 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 CK-MB CARTRIDGE |
| Generic Name | CK-MB CARTRIDGE |
| Product Code | MYT |
| Date Received | 2015-12-22 |
| Returned To Mfg | 2016-01-13 |
| Model Number | NA |
| Catalog Number | 03P92-25 |
| Lot Number | G15242 |
| Device Expiration Date | 2016-01-28 |
| 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 | 2015-12-22 |