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

Catalog Number	0020006800
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ptt specimen was initially analyzed at 5:56 am on acl analyzer with serial number (b)(6), producing a result of 102.1 seconds.Later in the day, at approximately 3:00 pm, the same specimen was reanalyzed on a different analyzer (sn: (b)(6)) and yielded a result of 23.5 seconds.This discrepancy was brought to attention following a physician inquiry regarding the unexpectedly prolonged initial result.To further investigate, a subsequent specimen was collected from the same patient and tested at 3:30 pm, resulting in values of 23.9 and 24.3 seconds, consistent with the repeat result and within the expected range.All quality control (qc) data including normal qc (lot: n1046514) and abnormal qc (lot: n0945748) was within acceptable limits both before and after the incident.The ptt synthasil reagent lot in use was n0542241.There was no impact on patient care, as the erroneous result was identified and corrected before any clinical action was taken.It was also noted that the customer site had not received preventive maintenance (pm) service since june 2023.The customer was advised that their account is billable and that a purchase order (po) will be required to schedule service for analyzer verification.
Additional Manufacturer Narrative
Sample result and qc statistic printout were provided, in addition to an instrument backup for review.Complaint investigation found that the quality control results were within range both before and after the potentially erroneous result.A review of the submitted instrument backup for acl top 300 cts sn (b)(6) sw 5.3.0 p 16.8.00, dated (b)(6) 2025, was performed.Hemosil normal control assayed qc showed recoveries of 27.9, 27.6 and 27.9 seconds were within package insert acceptance range on the day of the suspected erroneous result.Review of the instrument backup and submitted qc statistics report for hemosil high abnormal control assayed qc showed recoveries of 52.6, 53.0 and 52.2 seconds were within package insert acceptance range on the day of the suspected erroneous result.Review of the general log shows no instrument errors or warnings prior to sample run at 05:56:50.Review of the instrument backup and submitted sample result detailed reports identified all samples in question.A trace file analysis was performed on the submitted instrument backup.Analysis concluded that the sample probe detected fluid at approximately the same height for the first aptt-ss sample aspiration as it did for the subsequent pt-rp sample aspiration.This finding suggests it is highly likely there was a mis-aspiration of the sample.Review of the service history for acl top 300 cts sn (b)(6) was performed and confirmed that the last pm on this analyzer was on 6/19/2023.Per the acl top family operator's manual, chapter 13 - system preventive maintenance is to be performed by authorized service personnel every 6 months.On 7/14/2025, a pm was completed by the field service engineer and the red led was replaced.The instrument was verified and operational at completion of this part replacement.There was no patient impact, no remedial action is required.This information has been forwarded to the werfen risk assessment process and will be monitored through trending analysis.

• 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 2443
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 22731164
• Report Number: 1217183-2025-00038
• Device Sequence Number: 8884684
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240601(17)260531(10)N0542241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/06/2025

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: 05/31/2026
• Device Catalogue Number: 0020006800
• Device Lot Number: N0542241
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/06/2025
• 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