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); Device Issue (2379)

Patient Problems Transient Ischemic Attack (2109); Blurred Vision (2137); No Consequences Or Impact To Patient (2199)

Event Date 04/17/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value.(b)(6).Patient went to hospital due to blurred/double vision on (b)(6) 2016.Patient admitted to hospital for tia.Released from hospital on (b)(6) 2016, no medication given, no changes in medication.Patient's therapeutic range 2.0-3.0 prior to hospitalization and tia.Patient's new therapeutic range 2.5-3.5.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The customer's complaint was not replicated and no product deficiency was identified.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot met release specifications.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5660128
• MDR Text Key: 45334171
• Report Number: 2027969-2016-00320
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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: 384368A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATIONS
• Patient Outcome(s): Hospitalization