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

Catalog Number	00020014600
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Potentially erroneous result generated due to hit alternative predilution (d) test being ordered instead of the main test using hemosil hit-ab (pf4-h) lot b37012 on acl top 550 cts sn (b)(6).A complaint was submitted on hemosil hit-ab (pf4-h), lot b37012, pn 00020014600, indicating that a laboratory user mistakenly ordered and performed a hit alternative predilution (d) test instead of the standard hit_ab test on (b)(6) 2025.At this time, the impact on the patient remains unknown.
Additional Manufacturer Narrative
The certificate of analysis (coa) for hemosil hit-ab (pf4-h), lot: b37012, pn: 00020014600 was reviewed.The reagent met all required specifications, and no abnormalities were identified.Review of the submitted sample result report indicates that an on-board dilution test was performed.The laboratory user mistakenly ordered and performed a hit alternative predilution (d) test instead of the standard hit_ab test.The hit alternative predilution (d) test involves a 1:4 dilution of the patient's plasma.This process can lead to over-dilution of anti-pf4/heparin antibodies, especially in patients who already have a low concentration of these antibodies.To minimize this risk, it is recommended to perform the standard hit_ab test first and only proceed with the diluted test as defined in the werfen-locked test definition.Patient impact is unknown.Based on this assessment, no remedial action is required.This incident will be monitored through trending analysis.

• Brand Name: HEMOSIL HIT- AB(PF4-H)
• Common Device Name: PLATELET FACTOR 4 RADIOIMMUNOASSAY
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730 2443
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 22737450
• Report Number: 1217183-2025-00040
• Device Sequence Number: 18417971
• Product Code: LCO
• UDI-Device Identifier: 08426950975380
• UDI-Public: (01)08426950975380(11)240723(17)251231(10)B37012
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K153137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 00020014600
• Device Lot Number: B37012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown