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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Anemia (1706)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller (end user) alleged a variance between the inratio inr result and an alternate point of care (poc) inr result.Results are as follows: date: (b)(6) 2016, inratio inr: 1.3, poc inr: 2.3.Therapeutic range: 2.0 - 3.0.The time between testing was two (2) hours.The caller stated that after the poc inr result was received, the physician advised her to hold her warfarin for three (3) days and then to resume her normal dose.The caller reported that she is anemic.There was no hematocrit result provided.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history of strip lot was performed.In-house testing on the reported strip lot met accuracy criteria.The customer's complaint was not replicated.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was reported to be anemic.This condition may impact the performance of the assay.A 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 and no corrective action is required.

Event Description

The results, that were provided on the initial mdr submitted, were verified since it was reported that the warfarin was held based on a result that was in the therapeutic range.

• 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: 5417259
• MDR Text Key: 37701486
• Report Number: 2027969-2016-00082
• 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
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

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: 370763AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• 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
• Patient Outcome(s): Required Intervention