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 09/05/2019

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 05aug2018 to aware date 05sep2019.No other similar complaints were identified during the search period.The g8 variant operator's manual states the following: 1.8 limitations of the procedure.Hemoglobinopathies.Mathematical algorithms used in the software exclude hemoglobin variant peaks eluting after the a0 peak when calculating the total area.The sa1c% is usually not affected in such situations, although chromatograms should be carefully reviewed.Hbs, hbd and hbc elute after the a0 peak.The sa1c% is generally reportable on the g8 when these hemoglobins are present in the heterozygous state with hba.Glycemic monitoring for any patients displaying any homozygous hemoglobin (other than hbaa) such as hbss, hbcc or the double heterozygous sc, cannot be performed using sa1c because there is no hemoglobin a present.Alternative testing is mandatory for these types of patients.Interpretation of results.The sa1c measuring range is 4.0 - 16.9%.The ideal retention time for sa1c is 0.59 minutes.The ideal retention time for a0 is 0.90 minutes.Results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.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 probable cause is attributed to the end user.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported an erroneous sa1c result of 53.3% on the g8 analyzer.The customer stated the chromatogram showed no flags.The same patient sample was analyzed multiple times on both g8 analyzers and no flags were generated.The erroneous result was released to the physician; however, there was no patient impact as the physician questioned the result.The sample was sent for further testing by another methodology.Upon further troubleshooting, it was discovered that the customer did not have flag 2 (reportable range) set on both g8 analyzers.At this time, the customer has decided not to turn on the flag on both analyzers.The g8 analyzers are operating as intended.There was no indication of patient intervention or adverse health consequences due to the erroneous result.

• 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: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9158699
• MDR Text Key: 220516575
• Report Number: 8031673-2019-00378
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• 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: 10/04/2019

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2010
• 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