MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).Device by manufacturer: on (b)(4) 2015, a technical support specialist (tss) addressed the reported event where the customer informed that they had failed api survey.Tss sent a new column and calibrators for evaluation.Customer advised new column and calibrators resolved the unacceptable pt results.No further action required.The probable cause of the event was lot to lot variability.

Event Description

On (b)(6) 2015, a customer reported failed api survey with their g7 analyzer.Customer reports failed api survey on the g7.Gly-11 13.3 [9.7-14.7], gly 12 - 7.9 [4.6-7.0], gly 13 - 13.1 [7.3-11.1], gly 14 - 8.3 [4.0-7.0], gly 15 - 16.8 [9.5-14.4].Calibrated with lot zs4002, 1.1129x + 0.6655.(b)(4), fc 36.Reports that quality control (qc) mean for mas dbcl 1702 in sept was 6.2 and 9.8.L1 qc mean for oct was 6.4, l2 was still 9.8.Tss asked to see qc api report.Advised to perform the monthly monitoring check and recalibrate.Monthly maintenance checks - check dilution process - 6.3 /wash; 6.1/di.Check sampling process - 6.1 whole blood; 6.3 manual dilution.The customer is unable to run hba1c patient samples.A technical support specialist (tss) addressed the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: G7
• Type of Device: G7
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7380095
• MDR Text Key: 103972230
• Report Number: 8031673-2018-04139
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: G7: 019327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2018
• Distributor Facility Aware Date: 11/11/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/28/2018
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1