MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL READIPLASTIN 20 ML; PROTHROMBIN TIME TEST)

Model Number	00020301400
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the investigation, an applications consultant was dispatched to the customer site.They discovered that the customer's quality control was running out of range high for both levels.The customer reported patient results outside of the laboratory, despite failing quality control, which is not consistent with best laboratory practice.Additionally, a field service investigation was conducted that included a check of the customer's acl top 500 cts instrument function.All checks were within acceptable limits.This investigation confirmed that the acl top 500 cts performed as intended with no malfunction.Note: the reagent lot in use at the customer site (lot number n0806224 of hemosil readiplastin, part number 0020301400) has received several other customer complaints and therefore, we are taking the actions listed below.Remedial action/ corrective action/preventive action/field safety corrective action: although the customer should not have reported patient results due to failed quality control levels, we are expanding the current fda recall under z-0276-2022 (class ii) to also remove lot n0806224 of hemosil readiplastin, part number 0020301400, from the field.Following is an update: on february 14, 2022, a stop ship was issued on lot number n0806224 of hemosil readiplastin, part number 0020301400.On february 18, 2022, a notification was initiated to the field advising of the removal of lot number n0806224 of hemosil readiplastin, part number 0020301400, from the field.The removal of the additional lot of hemosil readiplastin will be reported into (b)(6), recall coordinator, under z-0276-2022.
Event or Problem Description
A complaint was received indicating that a customer reported erroneous patient clotting time results (inr; international normalized ratio) using hemosil readiplastin, part number 0020301400, lot number n0806224, on the acl top 500 cts.The inr results were reported outside of the laboratory despite the laboratory's quality control results exceeding the manufacturer's quality control package insert range.Per the customer, multiple patients with erroneously high inr results had their management altered (e.G., change in type of anesthesia, postponement of surgery).To date, there are no reported adverse events from these changes in management.

• Brand Name: HEMOSIL READIPLASTIN 20 ML
• Common Device Name: PROTHROMBIN TIME TEST)
• 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: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 13584277
• Report Number: 1217183-2022-00001
• Device Sequence Number: 20215438
• Product Code: GJS
• UDI-Device Identifier: 08426950632887
• UDI-Public: 08426950632887
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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 Expiration Date: 08/31/2022
• Device Model Number: 00020301400
• Device Catalogue Number: 0020301400
• Device Lot Number: N0806224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0276-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown