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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineering (fse) visited the customer to address the reported event.Fse confirmed p00 peaks and abnormal results by reviewing instrument printouts.Fse determined a possible system contamination and performed instrument decontamination procedure and replaced all reagents.Fse ran calibration and qc, all runs completed successfully within acceptable ranges.No further action required by field service.The g8 instrument is functioning as expected.The g8, serial number (b)(4), was installed on (b)(6) 2017.A complaint history review and service history review for similar complaints was performed from installation date to aware date.There were no other similar complaints identified during the searched period.The g8 operator's manual under chapter 1, introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.Interpretation of results: the sa1c measuring range is 4.0 - 16.9%.The ideal retention time for sa1c is 0.59 minutes.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.In chapter 5: maintenance procedure, section 5.3 elution buffer and hemolysis & wash solution replacement, provides detailed information on how to replace the buffers.The most probable cause of the reported event was due to biological contamination of the system due to operator error.

Event Description

A customer reported out of range high hemoglobin a1c (hba1c) results on nine (9) patient samples with the g8 analyzer.The customer reported that all nine (9) patient samples were part of the same run.The customer confirmed that quality controls (qc) were out of range high as well.The customer provided chromatograms for four (4) of the nine (9) patient samples with the following hba1c results: (b)(6).The chromatograms showed out of range high hba1c patient results and retention times.The ideal retention time is 0.59 minutes and stable a1c measuring range of 4.0 - 16.9 % (hba1c 4.0 - 6.0% reference range for non-diabetic).The chromatograms showed hb-var detect, check peaks, and sa1c >rr (reportable range) flags were generated by the g8 analyzer.These are indicative of abnormal patient results.The customer stated that all nine (9) high hba1c patient results were reported out of the lab.The customer repeated the patient results and sent out corrections to the physician.The customer suspected that the operator filled the buffer with a wrong reagent, which resulted in incorrect patient results.A field service engineer was dispatched to further investigate the reported event.There is no indication of any adverse health consequences or change patients treatment due to this event.

• 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8097454
• MDR Text Key: 129446855
• Report Number: 8031673-2018-05246
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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: 11/21/2018
• Distributor Facility Aware Date: 10/29/2018
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/21/2018
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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