MAUDE Adverse Event Report: TOSOH CORPORATION AIA-PACK BHCG CALIBRATOR SET; AIA-PACK BHCG

Model Number N/A

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

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

This problem was caused by lot to lot variation of a raw material, serum.In the acceptance inspection, an accelerated stability test is done to evaluate the stability of a new lot of serum.The problematic serum passed the test but deteriorated faster than expected.Risk assessment: for diagnosis of pregnancy, ifu shows non-pregnant reference value is < 0.5 miu/ml and it was reported that the hcg concentration is 5 to 50 miu/ml within the 1st week of pregnancy.It is also reported that hcg concentration doubles every 48 hr.During early pregnancy.Usually pregnancy is diagnosed in conjunction with ultrasonography.After hcg reached 1000 to 2000 miu/ml, the gestational sac could be observed by ultrasonography.Because of above mentioned dynamic change of hcg concentration, 20% higher hcg value do not seems to result in health hazard.

Event Description

A customer in (b)(6) reported that the measurement values of control (tosoh multi-control) were around or exceed upper value of assigned range.Internal investigation found poor stability of the calibrator set.Because of this, if this calibrator set were used around its expiration date, test results of patient samples as well as controls could be 20% higher than original value.

• Brand Name: AIA-PACK BHCG CALIBRATOR SET
• Type of Device: AIA-PACK BHCG
• Manufacturer (Section D): TOSOH CORPORATION; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH AIA, INC.; 2, iwasekoshi-machi; toyama, toyama 931-8 510; JA 931-8510
• Manufacturer Contact: hitoshi tashiro ; 3-8-2 shiba; minato-ku, tokyo, japan 10586-23 ; JA 1058623
• MDR Report Key: 10260684
• MDR Text Key: 207146480
• Report Number: 8031673-2020-50001
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 04560189211353
• UDI-Public: 04560189211353
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K870521
• 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: 07/10/2020

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 Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 0020361
• Device Lot Number: J833531
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• Type of Device Usage: Unknown
• Patient Sequence Number: 1