MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-05 for HEMOSIL ACUSTAR 0009801000 manufactured by Instrumentation Laboratory.
[135073680]
The instructions for use for the hemosil acustar anti-cardiolipin igg assay advises that definitive clinical diagnosis cannot be made on the basis of an acl igg positive result alone, and patient history and clinical findings must be considered. An investigation is currently in progress and a follow-up report will be filed upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135073681]
Customer reported that two pregnant patients were diagnosed with antiphospholipid syndrome based on a positive anti-cardiolipin igg (acl igg) results on the acl acustar and subsequently treated with low molecular weight heparin and acetylsalicylic acid/aspirin. During their pregnancy, each woman developed a uterine hematoma. Anticoagulation therapy was stopped after hematomas occurred. Additionally, one of the patients also experienced a spontaneous abortion at (b)(6) of gestation; however, the customer indicated that it was not possible to definitely determine the underlying cause of the aborted pregnancy, as she was a high-risk patient with previous miscarriages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2019-00002 |
| MDR Report Key | 8305305 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-05 |
| 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 | MS. REBA DAOUST |
| Manufacturer Street | 180 HARTWELL ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7818614597 |
| Manufacturer G1 | INSTRUMENTATION LABORATORY |
| Manufacturer Street | 180 HARTWELL ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSIL ACUSTAR |
| Generic Name | ACL ACUSTAR |
| Product Code | JPA |
| Date Received | 2019-02-05 |
| Catalog Number | 0009801000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY |
| Manufacturer Address | 180 HARTWELL ROAD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-05 |