MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL SYNTHASIL; ACTIVATED PARTIAL THROMBOPLASTIN

Catalog Number	0020006800
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was submitted on hemosil synthasil, pn 00020006800, lot n1147356 indicating erroneous aptt results generated on acl top 350 cts, sn (b)(6) on july 20, 2025 at 20:29 and 20:52.No known patient impact reported.A review of the certificates of analysis (coa) for hemosil synthasil, pn 00020006800, lot n1147356 was performed.The reagent met all specifications; no abnormalities were found.Review of specimen 1 and specimen 2 for test code aptt-ss (hemosil synthasil) yield failed results.Review of the qc statistic report for test code aptt-ss using hemosil normal control 1 shows 7 "failed" qc results after the sample in question was analyzed.Review of the qc statistic report for test code aptt-ss using abnormal control 3 shows 6 "failed" qc results after the sample in question was analyzed.A service call was initiated in response to the complaint.The field service engineer (fse) inspected the analyzer and identified that the rinse aspiration probe was not properly seated on the rinse bottle.After correcting the probe placement, the fse reran qc tests, which then recovered within acceptable limits.This confirmed that the improper placement of the rinse aspiration probe was the root cause of the erroneous aptt results.Therefore, no remedial action required.
Event or Problem Description
A complaint was submitted on hemosil synthasil, pn 00020006800, lot n1147356 indicating erroneous aptt results generated on acl top 350 cts, sn (b)(6), on july 20, 2025 at 20:29 and 20:52.The analyzer failed to produce numerical aptt values.Heparin contamination was initially suspected, prompting a redraw of the patient sample after ensuring that heparin had been suspended.However, the redraw specimen also failed to yield a numerical result.

• Brand Name: HEMOSIL SYNTHASIL
• Common Device Name: ACTIVATED PARTIAL THROMBOPLASTIN
• 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: 22853524
• Report Number: 1217183-2025-00039
• Device Sequence Number: 8403524
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)241201(17)261130(10)N1147356
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0020006800
• Device Lot Number: N1147356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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