MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY HEMOSIL ACUSTAR; ACL ACUSTAR

Catalog Number	0009801000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Miscarriage (1962)
Date of Event	01/29/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.Follow up narrative february 12, 2019: an investigation was conducted that included review of the hemosil anti-cardiolipin igg (acl igg) performance on the acl acustar.As part of this investigation, batch records for acl igg for the past two years were reviewed and the functional quality control (qc) results were determined to be consistent from lot-to-lot.Further, samples run during the functional qc were re-tested with the acl igg complaint lot and results were consistent with the original release data and the correlation coefficient met the specification criteria.Note: patient specific data and the instrument database were not provided by the customer for the investigation.Based on the above, hemosil anti-cardiolipin igg (acl igg) on the acl acustar is meeting specification and no remedial action is indicated.
Event or Problem Description
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 7-8 weeks 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.

• Brand Name: HEMOSIL ACUSTAR
• Common Device Name: ACL ACUSTAR
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• MDR Report Key: 8305305
• Report Number: 1217183-2019-00002
• Device Sequence Number: 1304228
• Product Code: JPA
• UDI-Device Identifier: 08426950498001
• UDI-Public: 08426950498001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0009801000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death