MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-24 for I-STAT CREA CARTRIDGE 03P84-25 manufactured by Abbott Point Of Care.
[126244142]
Apoc incident # (b)(4). Apoc labeling was evaluated during the investigation as pertaining to the event. The investigation was completed on 10/24/2018. A review of the device history record confirmed the lot passed finished goods release criteria. Retained cartridge testing met the acceptance criteria found in q04. 01. 003 rev. Ac, appendix 1- product complaint level 2 and level 3 investigation procedure. No deficiency has been identified.
Patient Sequence No: 1, Text Type: N, H10
[126244143]
On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat crea+ cartridges that yielded a suspected discrepant creatinine result on an (b)(6) year old male cancer patient. There was no additional patient information available at the time of this report. Return product is not available for investigation. (b)(6). Test and sample collection times were not provided. There are no injuries associated with this event. At this time there is no reason to suspect a malfunction exists. The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay. Based on the i-stat results it is suspected that the patient was taking hydroxyurea although the customer reported that hydroxyurea was not listed on medication list. The ordering doctor stated that the patient was on hydroxyurea back in (b)(6) 2018 but not now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2018-00262 |
| MDR Report Key | 8001409 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-28 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2018-07-04 |
| Date Added to Maude | 2018-10-24 |
| 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 CREA CARTRIDGE |
| Generic Name | CREA CARTRIDGE |
| Product Code | CGL |
| Date Received | 2018-10-24 |
| Model Number | NA |
| Catalog Number | 03P84-25 |
| Lot Number | A18185 |
| Device Expiration Date | 2018-12-31 |
| 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 | 2018-10-24 |