MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-19 for I-STAT CG4+ CARTRIDGE 03P85-25 manufactured by Abbott Point Of Care.
[130883877]
Apoc incident # (b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[130883878]
On 12/07/2018, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges (lot# unk) that yielded suspected discrepant results on an (b)(6) patient with diabetes. The customer stated that the patient was already very critical when admitted and later expired. Cause of death is unknown at the time of this report. There was no additional patient information available at the time of this report. Method, date, result, sample: i-stat, (b)(6) 2018, <0. 30 mmol/l, a. Architect, (b)(6) 2018, 11. 2 mmol/l, b. Lab, (b)(6) 2018, 10. 8 mmol/l, b. 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. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
[140019093]
Apoc incident # (b)(4). The investigation was completed on 02/19/2019. A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria. Retained testing met the acceptance criteria outlined in appendix 1 of q04. 01. 003 rev. Ac (product complaint level 2 and level 3 investigation procedure). No deficiency has been determined for cg4+ lot m18163a.
Patient Sequence No: 1, Text Type: N, H10
[140019094]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2018-00317 |
| MDR Report Key | 8180347 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-19 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2018-12-19 |
| 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 CG4+ CARTRIDGE |
| Generic Name | CG4+ CARTRIDGE |
| Product Code | KHP |
| Date Received | 2018-12-19 |
| Model Number | NA |
| Catalog Number | 03P85-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Death | 2018-12-19 |