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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
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 550 cts.Per the customer, one patient with an erroneously high inr result had their treatment adjusted with the administration of oral vitamin k.To date, there is no reported adverse event from the change in management.
Additional Manufacturer Narrative
As part of the investigation, a review of the acl top 550 cts back up was performed.In reviewing the customer's quality control (qc) records, there were multiple instances of qc out of range and qc results were trending upwards.Using a different vial of reagent, they obtained passing qc results at the upper end of acceptance.Patient samples in question were tested and the results released.A report on the qc results was internally reviewed by the laboratory supervisor the next day and the patient sample issue identified and the complaint filed.Note: the reagent lot in use at the customer site (lot number n0806224 of hemosil readiplastin, part number 0020301400) has received multiple customer complaints and therefore, we are taking the actions listed below.Remedial action/corrective action/preventive action/field safety corrective action: 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 (b)(6) 2022, a stop ship was issued on lot number n0806224 of hemosil readiplastin, part number 0020301400.On (b)(6) 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 dr.(b)(6), recall coordinator, under z-0276-2022.
Additional Manufacturer Narrative
As part of the investigation, a review of the acl top 550 cts back up was performed.In reviewing the customer's quality control (qc) records, there were multiple instances of qc out of range and qc results were trending upwards.Using a different vial of reagent, they obtained passing qc results at the upper end of acceptance.Patient samples in question were tested and the results released.A report on the qc results was internally reviewed by the laboratory supervisor the next day and the patient sample issue identified and the complaint filed.Note: the reagent lot in use at the customer site (lot number n0806224 of hemosil readiplastin, part number 0020301400) has received multiple customer complaints and therefore, we are taking the actions listed below.Remedial action/corrective action/preventive action/field safety corrective action: 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 (b)(6) 2022, a stop ship was issued on lot number n0806224 of hemosil readiplastin, part number 0020301400.On (b)(6) 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 dr.(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 550 cts.Per the customer, one patient with an erroneously high inr result had their treatment adjusted with the administration of oral vitamin k.To date, there is no reported adverse event from the change 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: 13620718
• Report Number: 1217183-2022-00002
• Device Sequence Number: 4410650
• Product Code: GJS
• UDI-Device Identifier: 08426950632887
• UDI-Public: 08426950632887
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/28/2022

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
• Device Expiration Date: 08/31/2022
• Device Model Number: 00020301400
• Device Catalogue Number: 0020301400
• Device Lot Number: N0806224
• 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: 02/18/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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