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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Unspecified Infection (1930)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

Variance was reported between inratio inr and lab inr results.The results were as follows: on (b)(6) 2016, inratio = 3.2, lab = approximately 4 (1 hour).On (b)(6) 2016, inratio = 1.8, lab = 4.9 (1 hour).The reported therapeutic range: 2.5-3.5 patient had been hospitalized for a severe diabetic infection (date of admittance not provided).After being discharged from the hospital a lab inr=4.9 and later an inratio inr=1.8 performed by the physician.Patient was treated based on the lab results.

Manufacturer Narrative

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 accuracy criteria.The product performed as expected.The customer's complaint was not replicated.A review of the manufacturing batch records for the reported strip lot12 was performed: the lot met release specifications.The customer was reported to have a severe infection and lung cancer; these conditions may impact the performance of the assay.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 rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5684212
• MDR Text Key: 46080894
• Report Number: 2027969-2016-00401
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

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: 386291A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2016
• 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
• Patient Sequence Number: 1
• Treatment: LIPITOR
• Patient Outcome(s): Required Intervention