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 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 23-mar-2018 through aware date 23-apr-2019.There were no other similar events reported during the searched period.The st aia-pack hba1canalyte application manual states the following: limitations of the procedure: for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: 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.The most probable cause of the reported event was due to an abnormal patient sample, as indicated by the chromatography, which was not properly reviewed by the operator prior to being reported out of the laboratory.

Event Description

A customer reported that a physician questioned an initial hemoglobin a1c (hba1c) patient result of 4.2% obtained with the g8 analyzer.The customer repeated the same patient sample and obtained an hba1c result of 3.9%.The customer sent the patient sample to a reference lab for confirmation, which obtained an hba1c result of 9.0%.The customer reported that quality controls were within acceptable range.The technical support specialist (tss) reviewed the chromatograms provided by the customer and noticed that the stable a1c peak was split, causing the low hba1c patient result.No check peaks or hbe variant flags were generated on either patient result on the g8 analyzer.The customer indicated that the patient was previously ran in (b)(6) 2018 and at that time the sample was flagged with hbe suspected (flag 43) and check peaks (flag 24) flags with no result reported on hba1c.The tss verified that all flags suggested by tosoh were installed and active, including hbe suspected (flag 43) and check peaks (flag 24).The chromatograms of this event had obvious abnormalities with the stable a1c peak that could have been confirmed by a visual review, as indicated by the g8 variant analysis mode operator's manual.For future reference, the tss suggested to the customer to contact tosoh technical support for questionable chromatograms for assistance in determining whether the result is reportable.There is no indication of any adverse health consequences as a result of 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, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 8625972
• MDR Text Key: 204239175
• Report Number: 8031673-2019-00172
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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