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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AIA-PACK BHCG
• Manufacturer (Section D): TOSOH CORPORATION; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10260684
• Report Number: 8031673-2020-50001
• Device Sequence Number: 2853334
• Product Code: JHI
• UDI-Device Identifier: 04560189211353
• UDI-Public: 04560189211353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1