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

Model Number 100071

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/24/2014

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown.Investigation/conclusion: since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "serious bodily injury" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.If additional information is received, a supplemental medwatch form will be completed and submitted.

Event Description

This event was identified as part of an evaluation in which insurance claims/filed suits communicated to alere legal had not been forwarded to alere (b)(4) for investigation.Alere legal received a complaint communication on 08/13/2015 and forwarded it to (b)(4) on 09/08/2015.Regarding the event, there is limited information available from the communication.Complainant alleged "serious bodily injury as a result of proper and directed use of the inratio2 system." there were no inr results, event description or event date reported.Historical information received from (b)(6).Enrolled in (b)(6) services in (b)(6) 2012.Historical inratio inr results: (b)(6) 2014: inratio inr=2.0, (b)(6) 2014: inratio inr=3.0, (b)(6) 2014: inratio inr=2.9, (b)(6) 2014: inratio inr=2.1, (b)(6) 2014: inratio inr=2.0 "last treatment date".The patient's therapeutic range was 2.5 - 3.5.The patient was discharged from ahm services on (b)(6) 2014.There was no reason provided as to why the service was stopped.Per (b)(6) documentation system, the patient did not report any result issues or injury events.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "serious bodily injury" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Product problem checked.Conservatively reporting as a "product problem" due to the variance between the historical inratio inr results and the inability to obtain information to determine if a medication change may have caused the variance.

• 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: 5069474
• MDR Text Key: 25484341
• Report Number: 2027969-2015-00662
• 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: company representative,other
• Reporter Occupation: Attorney
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR