MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

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

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The distributor field service engineer (fse) arrived at the site to address the reported event.Fse adjusted the dichroic mirror because it was out of alignment.After the adjustment, chromatograms returned results as expected.No further issues were noted.No further action was required by the distributor.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 06nov2017 through (b)(4) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 1- introduction and applications, states the following: chapter 1: interpretation of results: the chromatogram must be examined for any unidentifiable peaks (i.E., p00, p01,) before the a0 peak.Do not report the result if these peaks exist.When there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator's manual.The most probable cause of the reported event was due to the detector inadvertently being moved out of alignment after pm was performed.

Event Description

It was reported by the distributor that after periodic maintenance (pm), all the chromatograms from their g8 analyzer returned bad results with countless peaks, and there was noise coming from the detector.The analyzer was down.The distributor field service engineer was dispatched to address the reported event, which resulted in a delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH CORPORATION; 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,
• MDR Report Key: 8338979
• MDR Text Key: 138252078
• Report Number: 8031673-2019-00021
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: CJ
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2019,02/14/2019

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: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Distributor Facility Aware Date: 12/06/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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