MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.
[44378037]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44378038]
On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result on a (b)(6) female patient presented for right upper quadrant abdominal pain. The pregnancy test was administered before performing x-rays. There was no additional patient information at the time of this report. The patient was given a transvaginal ultrasound, which confirmed the patient was not pregnant. The patient was given an appendectomy and later discharged. The customer states that return product is available for investigation. Date: (b)(6) 2016, method: i-stat, result: 36. 5. On (b)(6) 2016, vista, <1. Based on the information available and internal control algorithms the event is reportable as a potential product malfunction although not confirmed at this time. There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
[45241564]
(b)(4). The investigation was completed on 05/03/2016. Customer returns and retain product was tested and are functioning according to specification.
Patient Sequence No: 1, Text Type: N, H10
[45241605]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00019 |
| MDR Report Key | 5608576 |
| Date Received | 2016-04-26 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2015-11-26 |
| Date Added to Maude | 2016-04-26 |
| 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 B-HCG CARTRIDGE |
| Generic Name | B-HCG CARTRIDGE |
| Product Code | NAL |
| Date Received | 2016-04-26 |
| Returned To Mfg | 2016-04-20 |
| Model Number | NA |
| Catalog Number | 05P58-25 |
| Lot Number | A15330A |
| Device Expiration Date | 2016-04-28 |
| 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 | 2016-04-26 |