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

Model Number 200432

Device Problem Low Test Results (2458)

Patient Problems Anemia (1706); Dyspnea (1816); Test Result (2695)

Event Date 12/17/2014

Event Type  Injury  

Event Description

"caller alleged discrepant results compared with the lab.Results as follows:" date, inratio, lab: (b)(6) 2014, 1.2, ---; (b)(6) 2014, ---, 5.2.Patient self tester's therapeutic range: 2.0-3.0.There was milking of the patient self tester's finger after the fingerstick; finger touched sample well when applying sample.Patient self tester (pst) was admitted to the hospital on (b)(6) 2014 for shortness of breath; inr was 5.2 so pst's warfarin was held.Her son was not sure how long her warfarin dose was held but the usual dose of 4mg was resumed on (b)(6) 2014, the day after pst was discharged.Upon admittance to the hospital, pst was found to be anemic and was given blood to treat the anemia; she was discharged on (b)(6) 2014.No discharge diagnosis was available.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned and retain strips for lot# 350587 were not available, a review of in-house testing was performed.Lot # 350588 was used for internal investigation purposes to evaluate the performance of the master lot.Lot# 350588 that is identical except for the outer packaging and labeling as lot# 350587.Retain strip testing results from lot# 350588 and 350587 met both accuracy and repeatability criteria.The products performed as expected and no product deficiencies were observed.The manufacturing records for lot# 350588 and 350587 were reviewed.The lots met specifications and no non-conformances were documented.Capa investigation (capa-(b)(4)) has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have anemia but a hematocrit was not provided.This capa has identified anemia as a condition that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.Since the meter was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Root cause is unable to be determined at this time without product return.Further investigation is being performed under capa-(b)(4).

Manufacturer Narrative

Brand name changed from inratio pt/inr test strips to inratio 2 pt monitoring system.Model number changed to that of the inratio 2 pt monitoring system and serial number is included instead of strip lot number.Device is available for evaluation.Inratio pt/inr test strips listed instead of inratio monitor.The 510(k) listed is for the monitor rather than the strips.Device is evaluated by manufacturer and summary included.The monitor is not labeled for single use.Recall is indicated.Includes recall reporting number.The product associated with the complaint was returned for investigation.The complaint was not confirmed during in-house investigation.The customer reported a discrepant issue on lot# 350587.However, at the time of the investigation, retains for this lot were no longer available.As a result, lot # 350588 was used for internal investigation purposes to evaluate the performance of the master lot.Lot# 350588 is identical except for the outer packaging and labeling as lot# 350587.The returned meter met both accuracy and repeatability criteria and passed functional testing during an in-house investigation.The impedance curve analysis associated with this case found the curve exhibited a weak slope change.Our capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, sepsis) can contribute to weak slope change impedance curves.The patient is reported to be anemic at the time of the alleged discrepant result.Capa(b)(4) has identified anemia as a condition that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is the patient condition anemia which may have contributed to an impedance curve that exhibited a weak-slope change.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.

• 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: 4541517
• MDR Text Key: 5510905
• Report Number: 2027969-2015-00132
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Device Lot Number: 350587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• 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: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR, SN: (B)(4); WARFARIN; CIPRO AND SECOND UNKNOWN ANTIBIOTIC
• Patient Outcome(s): Hospitalization; Required Intervention