MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO 2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

The monitor associated with the complaint was returned for investigation.The customer's complaint was not confirmed during in-house testing.Retain strips tested on the returned monitor met accuracy criteria.When reviewing the entire in-house testing history for lot 372984a, it was found that the lot meets release criteria.The product performed as expected.A review of the manufacturing records for lot 372984a did not uncover any non-conformances.The returned monitor passed functional and thermistor testing requirements during in-house investigation.The impedance curve associated with the customer's inratio inr result of 3.4 was statistically analyzed and concluded to be normal in shape.However, the impedance curve associated with their result of 1.9 was concluded to exhibit weak-slope change.Capa(b)(4) has determined that impedance curves with weak slope change can cause discrepant results.The inratio monitor software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.There are no known medical conditions provided by the customer that would interfere with the test.Capa(b)(4) identified impedance curves with weak slopes as potentially leading to discrepant inr values.Further investigation is being performed under capa (b)(4) for this issue.

Event Description

The caller alleged a variance between inratio inr results and the lab inr results.The results were as follows: (b)(6) 2015 inratio inr=1.9, lab inr=1.6; (b)(6) 2015 inratio inr=3.4, lab inr=2.4.The patient self tester's therapeutic range is: 2-3.Peggy, the wife of the patient self tester, reported that two comparisons between a new box of inratio strips and lab were performed.She stated that the inratio results continue to be higher than the lab results (see above).

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention devices of the reported lot.Retention devices were tested with hcg urine cutoff control (25 miu/ml) and 3 high level hcg urine standards (211.5 iu/ml, 217.5 iu/ml, and 218.1 iu/ml).All of the results were hcg positive at read time and met the qc release specification.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: INRATIO 2 PT MONITORING SYSTEM
• 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: 5368037
• MDR Text Key: 36239693
• Report Number: 2027969-2016-00026
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1