MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for I-STAT ACT CELITE CARTRIDGE 03P86-25 manufactured by Abbott Point Of Care.
[37741678]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[37741679]
On (b)(6) 2016, abbott point of care was contacted by a customer regarding actc cartridge that yielded 6 consecutive star outs (***) on actc cartridge lot# r15288b on a cardiac patient. The event occurred on (b)(6) 2015 and after the last star out they switched to another cartridge lot without issue. There was no patient information at the time of this report. The customer states that return product is available for investigation. Per i-stat system manual, art: 714374-00m, rev. Date: 02-sep-2015: instead of results- stars appear in place of results if the analyzer detects that the sensor's signal is uncharacteristic. Since the sensor check is part of the i-stat quality system, an occasional result will be flagged due to a bad sensor. Other causes of this flag are improperly stored cartridges or an interfering substance in the patients sample, either extrinsic, such as the wrong anticoagulant, or intrinsic such as medication. Also, aged samples may contain products of metabolism that can interfere with the tests. (b)(6). There are no injuries associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[41634711]
(b)(4). The investigation was completed on (b)(6) 2015. Customer returns and retain product was tested and are functioning according to specification.
Patient Sequence No: 1, Text Type: N, H10
[41634712]
Na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00005 |
| MDR Report Key | 5402777 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-03-31 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2015-10-15 |
| Date Added to Maude | 2016-02-01 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT ACT CELITE CARTRIDGE |
| Generic Name | ACT CELITE CARTRIDGE |
| Product Code | JBP |
| Date Received | 2016-02-01 |
| Returned To Mfg | 2016-01-11 |
| Model Number | NA |
| Catalog Number | 03P86-25 |
| Lot Number | R15288B |
| Device Expiration Date | 2016-03-28 |
| 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 | 2016-02-01 |