MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-10 for I-STAT CREA CARTRIDGE 03P84-25 manufactured by Abbott Point Of Care.
[90331672]
Apoc incident # (b)(4). Apoc labeling was evaluated during the investigation as pertaining to the event. The investigation was completed on 11/09/2016. Retain product was tested and functioning according to specification. Return product is not available for investigation. Investigation: a review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria. Retained test data met the acceptance criteria outlined in appendix 1 of q04. 01. 003 rev. Z (product complaint level 2 and level 3 investigation procedure). No deficiency was identified. Assessment: no repeats on the i-stat or the laboratory. Two different samples tested. The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.
Patient Sequence No: 1, Text Type: N, H10
[90331673]
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded suspected discrepant creatinine result on a (b)(6) year old male patient presented to the emergency room for a cough. Creatinine was tested to determine if contract should be given before imaging. There were no injuries associated with this event, the patient was treated based on the lab results. There was no repeat on i-stat. There was no additional patient information available at the time of this report. Return product is not available for investigation. I-stat, 1. 7, resulted at 12:51, cobas 0. 8, collected at 13:31, resulted a approximately 13:50. At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2017-00488 |
| MDR Report Key | 6939424 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2016-05-07 |
| Date Added to Maude | 2017-10-10 |
| 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 | 2017-10-10 |
| Model Number | NA |
| Catalog Number | 03P84-25 |
| Lot Number | A16128 |
| Device Expiration Date | 2016-10-28 |
| 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 | 2017-10-10 |