MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 G11

Model Number G11

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

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

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The tosoh automated glycohemoglobin analyzer hlc-723 g11 is not approved for use in the united states; however, it is a similar device to us-approved tosoh automated glycohemoglobin analyzer hlc-723g8.(b)(4).Device evaluation by manufacturer: the distributor field service engineer (fse) followed up with the customer over the phone to address the reported event.During troubleshooting, the customer reported to the distributor fse that the instrument was not connected to an uninterruptible power source (ups).Additionally, the customer reported that the city's power was not fluent having periods of outages.The customer was advised to install a ups immediately, which seemed to fix the issue.There were no further discrepant results or abnormal chromatograms reported.There was no further action required by the distributor fse.A complaint history review and service history review for similar complaints was performed on serial number (b)(4) from 17-sept-2018 through aware date (b)(4) 2019.There were no similar complaints identified during the searched period.The instrument was installed on 17-sept-2018.The g11 operator's manual under chapter 1, introduction, states the following: chromatogram: some fractions may be eluted out with different peak shapes or not be detectable depending up on the sample.If you observe the same phenomena with several different samples, the assay conditions may not be optimal or the reagent or column many have deteriorated.If there are shoulders or splits around the s-a1c or a0 peak, the column may have deteriorated.Replace the elution buffers or column and runt he assay again.If you observe an anomalous result with a single specific sample, the sample may have deteriorated or hemoglobin variants may be present.The chromatogram pattern for hemoglobin variants differs from that of normal sample, and it is difficult to measure an accurate hba1c% with the analyzer.Error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.221 #### not detect (#### is the peak id): a specific peak (hemoglobin fraction) could not be detected.When this occurs repeatedly with some samples, the elution buffer may have become concentrated, resulting in unidentified peak detection on chromatograms.When the error only occurs with specific samples, a hemoglobin variant may be present.Safety precautions state the following: connect an appropriate power source: connect to the power supply which gives sufficient power capacity and little voltage variation.Fire may occur if the power capacity is insufficient or the voltage exceeds the specifications.The most probable cause of the reported event was instrument needed to be connected to a ups source.

Event Description

A distributor reported to the tosoh field application specialist (fas) that a customer was getting random 221 ##### not detect error messages and high hemoglobin a1c (hba1c) results on patient samples with the g11 instrument.The customer reported that the issue occurred one or two times during the day and upon repeat all patient samples obtained acceptable hba1c results.No patient results were reported out of the lab; therefore, there was no impact to patient management.

• Brand Name: TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 G11
• Type of Device: G11
• 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; 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: 8380723
• MDR Text Key: 138255736
• Report Number: 8031673-2019-00031
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G11
• Device Catalogue Number: 0023850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2019
• Distributor Facility Aware Date: 02/04/2019
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 02/28/2019
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2017
• 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