MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL HIT- AB(PF4-H); PLATELET FACTOR 4 RADIOIMMUNOASSAY

Catalog Number 0020014600

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Customer reported two complaints regarding a negative result for hit-ab run on two separate acl top 700 instruments.A separate report (1217183-2024-00002) has been filed for the sample analyzed on acl top 700 serial number (b)(6).It was reported that a patient suspected of hit received a negative result on the acl top 700 serial number (b)(6).Other methods of testing (elisa and sra) were positive.The customer considers the negative result from the acl top 700 erroneous.The negative result from the acl top 700 was not reported, as the positive elisa test fit the patient's profile.No corrected report was issued and there was no impact to the patient.

Manufacturer Narrative

This is an initial report.Investigation is ongoing.The reportability is based on the assessment that treatment could have changed based on the negative result and potentially caused harm.

• Brand Name: HEMOSIL HIT- AB(PF4-H)
• Type of Device: PLATELET FACTOR 4 RADIOIMMUNOASSAY
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 19175720
• MDR Text Key: 340965208
• Report Number: 1217183-2024-00003
• Device Sequence Number: 1
• Product Code: LCO
• UDI-Device Identifier: 08426950975380
• UDI-Public: 08426950975380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Catalogue Number: 0020014600
• Device Lot Number: B36074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1