MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Ulcer (2274); Test Result (2695)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The following information was reported via telephone call on (b)(6) 2016.On (b)(6) 2016, the inratio inr result was 4.2, therapeutic range was 2.5 - 3.5.The patient presented to the hospital and was hospitalized for a bleeding ulcer.The laboratory inr was 10.The time between the inratio inr and the laboratory inr testing was a "couple" hours.Treatment included iron medication and holding the patient's coumadin from (b)(6) 2016.On (b)(6) 2016, the laboratory inr was 1.9 and the patient resumed her coumadin.The patient was discharged from the hospital on (b)(6) 2016.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: as of 04/14/2016, the product was not returned for evaluation.Therefore, a review of the in-house testing history of the lot was performed.In-house testing on strip lot 372984a was found to be performing within expectations.The manufacturing records for the lot were reviewed and the lot met release specifications.A root cause could not be determined from the information provided by the customer.Further investigation performed under capa (b)(4) which was initiated to investigate highly discrepant results.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5500607
• MDR Text Key: 40340210
• Report Number: 2027969-2016-00164
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 372984A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention