MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-14 for ARCHITECT TOTAL B-HCG 07K78-30 manufactured by A.i.d.d Longford.
[176773350]
(b)(4). An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[176773351]
The account stated on (b)(6) 2019 a patient generated a false negative architect total bhcg (<1. 2 miu/ml) result but the urine pregnancy test was positive. Additional testing was performed by roche platform with a negative hcg result. The negative architect total bhcg result was reported out of the laboratory. More than 20 days later ((b)(6) 2019), the patient was rushed to the hospital and found that the fallopian tube ruptured and the diagnosis was ectopic pregnancy. One side of the fallopian tube was removed. Additional patient testing was progesterone of 1. 7 ng/ml, tsh of 2. 09 miu/l and positive urine pregnancy test on (b)(6) 2019. No additional patient information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2019-00319 |
| MDR Report Key | 9321995 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-11-14 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-11-03 |
| Date Added to Maude | 2019-11-14 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | A.I.D.D LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT TOTAL B-HCG |
| Generic Name | B-HCG |
| Product Code | DHA |
| Date Received | 2019-11-14 |
| Catalog Number | 07K78-30 |
| Lot Number | 01177UI00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.I.D.D LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-11-14 |