MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.
[39452092]
Apoc incident # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39452093]
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 results on a(b6) female patient presented in the emergency room with groin pain. There was no additional patient information at the time of this report. The customer states that an ultra sound was done in the er which verified that the patient was not pregnant. (b)(6). 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
[41738950]
(b)(4). The investigation was completed on 03/11/2016. The customer initially implicated b-hcg cartridge lot# a15286. However, on 03/01/2016 the customer returned b-hcg cartridge lot# a15313a as the affected lot for investigation. Customer returns and retain product was tested and are functioning according to specification. Lot# changed from b-hcg cartridge lot# a15286 to cartridge lot# a15313a.
Patient Sequence No: 1, Text Type: N, H10
[41738951]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00015 |
| MDR Report Key | 5464629 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2016-03-11 |
| Device Manufacturer Date | 2015-11-09 |
| Date Added to Maude | 2016-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2016-02-26 |
| Returned To Mfg | 2016-03-01 |
| Model Number | NA |
| Catalog Number | 05P58-25 |
| Lot Number | A15313A |
| Device Expiration Date | 2016-04-14 |
| 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 | 2016-02-26 |