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 B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.
[37531583]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37531584]
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 of 41. 3 on a (b)(6) female patient presented in the emergency room with fever, sepsis and urinary tract infection (uti). The test was repeated on an alternate method and the result was <5. 0 based on the information available. The patient was admitted at this time. There was no additional patient information at the time of this report. Date: (b)(6) 2015, time: 07:46, method: i-stat, result: 41. 3, comment; (b)(6) 2015, 08:03, dxc, <5. 0, (positive >25). There was no repeat on the i-stat and at this time there is no reason to suspect that a malfunction exists. New information was received on 01/29/2016 from the facility stating that inpatient records indicated that the patient was not pregnant. 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
[38254302]
Apoc incident # (b)(4). The investigation was completed on 02/08/2015. Retain product was tested and is functioning according to specification. Return product was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[38254303]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00006 |
| MDR Report Key | 5402166 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-02-12 |
| Date of Event | 2015-12-30 |
| Date Mfgr Received | 2016-02-08 |
| Device Manufacturer Date | 2015-11-09 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT B-HCG CARTRIDGE |
| Generic Name | B-HCG CARTRIDGE |
| Product Code | NAL |
| Date Received | 2016-02-01 |
| Model Number | NA |
| Catalog Number | 05P58-25 |
| Lot Number | A15313 |
| Device Expiration Date | 2016-04-14 |
| 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 | 2016-02-01 |