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 01/12/2019

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 application specialist (das) arrived at the customer's site to address the reported event.The das noted chromatograms with abnormally elevated peaks and no separation between the stable a1c and the a0 peak, and high retention times.The das evaluated the instrument and found that the column count was over 3000 injections and proceeded to replace it.The das performed calibration and ran qc with acceptable results and no further random alterations of peaks.However, the das noticed that the retention time was fast and made adjustments until the retention time was within acceptable range and a normal chromatogram.There was no further action required; the g11 was operating as expected.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 17jan-2019.There were no similar complaints identified during the searched period.The instrument was installed on (b)(6) 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.Checks before assay states the following: 2 column and filter count numbers: be sure to check filter count numbers and replace the filter when the following replacement period has passed.The column is replaced as needed.5.9 column replacement: replace the column in the following situations.When the pressure is more than what is indicated on the column inspection report + 4 mpa and is not reduced by filter replacement.When peaks on the chromatogram (particularly the shaded sa1c peak) have become broad or broken into two fractions.Caution: if this phenomenon is observed only with a specific sample, column deterioration may not be the cause.Other factors, such as a hemoglobin variant, could be the cause.When assay results for quality control samples are consistently out of the assigned ranges even after re-calibration.When the calib error persistently occurs.Please contact technical support if the above issues are not resolved after column replacement.6.3 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.(b)(6) #### 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.The most probable cause of the reported event was the column count was over 3000 injections.

Event Description

A distributor application specialist reported to the tosoh field application specialist (fas) that a customer was getting random "221 #####" not detect error messages and abnormal hemoglobin a1c (hba1c) patient results on the g11 instrument.The customer reported that hba1c were within expected range upon repeat.The customer provided chromatograms for five patient samples.One patient sample obtained an initial hba1c result of 4.9% with no peaks or an unknown peak being detected; repeated result obtained a hba1c result of 10.5% three days later (refer to associated mfr report #: 8031673-2019-00029 / uf/importer report #: (b)(4), mfr report #: 8031673-2019-00039 / uf/importer report #: (b)(4), and mfr report #: 8031673-2019-00040 / uf/importer report #: (b)(4) for the four three events).No abnormal patient results were reported out of the lab.The customer reported that the instrument was calibrated every 30-days and bio-rad quality controls (qc) were within acceptable ranges.The distributor application specialist (das) was dispatched to the customer's site to further investigate the reported event.There was no indication of patient intervention or adverse health consequences due to the out of range high hemoglobin a1c patient result.

• 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: 8402057
• MDR Text Key: 142106851
• Report Number: 8031673-2019-00038
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: 03/07/2019
• Distributor Facility Aware Date: 01/17/2019
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 03/07/2019
• Date Manufacturer Received: 01/17/2019
• 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