MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.
[38155132]
Apoc incident # (b)(4). The investigation was completed on 01/14/2016. The customer observed an indeterminate result from ss-hcg cartridge lot m15234a that was considered discrepant from the laboratory instrument. A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria. A deficiency has been identified for ss-hcg cartridge lot m15234a. While cartridge testing met the acceptance criterion for the rate of detected errors (dts), the acceptance criterion for the rate of undetected errors (udts) was not met. Root cause will be investigated as part of exception report (er) 375028.
Patient Sequence No: 1, Text Type: N, H10
[38155133]
On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer who observed an indeterminate result from b-hcg cartridge lot m15234a that was considered discrepant from the laboratory instrument. There was no patient information at the time of this report. Date: (b)(6) 2015, time: unk, method: i-stat , result: 22; (b)(6) 2015, unk, beckman, 0. 00. Per i-stat system manual, art: 730474-00a, rev. Date: (b)(6) 2015: quantitative b-hcg: < 5. 0 iu/l, result qualitative b-hcg interpretation: negative, handheld display: hcg qual ( - ); 5. 0 - 25. 0 iu/l, indeterminate, hcg qual ( ); > 25. 0 iu/l, positive, hcg qual ( + ). There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00011 |
| MDR Report Key | 5414120 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-05 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-01-14 |
| Device Manufacturer Date | 2015-08-22 |
| Date Added to Maude | 2016-02-05 |
| 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 | 0 |
| Brand Name | I-STAT B-HCG CARTRIDGE |
| Generic Name | B-HCG CARTRIDGE |
| Product Code | NAL |
| Date Received | 2016-02-05 |
| Returned To Mfg | 2015-12-15 |
| Model Number | NA |
| Catalog Number | 05P58-25 |
| Lot Number | M15234A |
| Device Expiration Date | 2016-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-02-05 |