MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

Patient Problems Pain (1994); Renal Failure (2041); Urinary Retention (2119); No Consequences Or Impact To Patient (2199); Lymphoma (3263)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

Caller reported variance between inratio inr and lab inr results.The results were as follows: (b)(6) 2015: lab inr (5am)=5.0, inratio inr(1pm)=2.9, lab inr(3pm)=6.4, the patient's therapeutic range: 2-3.Patient was hospitalized for severe back pain and inability to urinate.He was diagnosed as having kidney failure and non-hodgkins b lymphoma.Over the next 5 months patient received 6 sessions of chemotherapy, multiple blood transfusions, and was released as stable and as "non-detect" to presence of cancer on (b)(6) 2016.It was reported that the patient was not hospitalized or treated based off of any inratio inr values.The caller also reported a variance between inratio inr and alternate poc meter.The results were as follows: (b)(6) 2016: alternate poc inr=2.5, inratio inr=1.8.It was reported that the inratio strips were no longer within their expiration date at this time.

Manufacturer Narrative

Corrections: brand name changed to "inratio2 pt/inr monitoring system." model # changed to "200432." delete lot #370763ar.Add serial # "(b)(4)." device available for evaluation changed to "yes"; returned to manufacturer: "08/02/2016." concomitant device changed to "inratio pt/inr test strips, pn 100071, lot 367839a" date received by manufacturer changed to "09/26/2016." pma/510(k) changed to "k072727." labeled for single use changed to "no." usage of device changed to "reuse." the meter associated with the complaint was returned for investigation.Functional and thermistor testing were performed on the returned meter with passing results.Strip investigation was not performed on the returned meter due to the recovered impedance curves associated with the customer's reported inr results being identified as having a weak-slope change.Although the customer was identified as having a condition that may impact the performance of the assay, the issue of weak-slope changes is related to the algorithm software on the meter and is known to contribute to discrepant results.A review of the entire testing history for the reported lot was performed.In-house testing for this lot met release specifications.No product deficiency was found.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot met release specifications.This issue was addressed in (b)(4).

• Brand Name: INRATIO2 PT/INR 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: 5844130
• MDR Text Key: 52287953
• Report Number: 2027969-2016-00542
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Device Lot Number: 367839A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• 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