MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-04-07 for BREATH TEK UBT KIT manufactured by Otsuka America Pharmaceutical Inc..
[21469231]
Case description: information received on (b)(6) 2014: a pregnant female consumer, age unknown, reported using pranactin citric, 1 dose, on an unknown date as preparation for the breath tek test for an unknown indication. This consumer reported taking pranactin citric once on an unknown date while 23 weeks pregnant. She reported on an unknown date after taking pranactin citric she did an hour long test and a 4 hour test for blood sugars and both were high. It was unknown if the blood sugar readings post pranactin citric are higher than those prior to the test. As of (b)(6) 2014 she has completed her use of pranactin citric and her blood sugars continued to be high; she has not seen her physician yet, but was not aware of any problems with the baby. Lot and expiration date were not provided. Relevant medical history included being borderline for gestational diabetes. The patient's relevant past drug history and concomitant medications are unknown.
Patient Sequence No: 1, Text Type: D, B5
[21621360]
Follow-up information received on (b)(6), 2014: spoke to the reporter and her mother. The patient was worried about the use of breath tek while pregnant. The patient declined consent to contact her physician. And she still has to think about it and discuss it with her obgyn. She wanted more information on the use of breathtek in pregnant women. Follow-up information received on (b)(6) 2014: this laboratory supervisor reported on a pregnant woman in her 20's who took pranactin citric, 1 dose, in (b)(6) 2013 as preparation for the breath tek test for h. Pylori. Relevant medical history, concomitant medications,a nd drug history are unknown. The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero. Lab data was unknown. As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown. Lot and expiration date are unknown. Follow up received (b)(6) 2015: the pqc investigation closed record was received. The summary was as follows: follow-up information was received on (b)(6) 2014. Product quality investigation completed ((b)(4)). The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero. Lab data was unknown. As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown. Lot and expiration date are unknown. The prescribing information (revision may 2013) for breath tek ubt for h. Pylori kit was reviewed by the qm complaint unit. Section 4 (warning and precautions) states the following: "pregnancy. No information is available on use of the pranactin-citric solution during pregnancy". Therefore, the root cause of the reported issue is documentation failure (no information available) regarding the prescribing information. The complaint is confirmed. Based on the product quality complaint investigation results, the root cause of the complaint is "documentation failure" and there is no reported device malfunction. This report from pqc perspective does not meet the requirement for mdr reportability. This report was previously submitted under mfg report number 3000718406-2014-00001. This report and all subsequent follow-ups will be submitted under mfg report number 9107159-2015-00004. Otsuka's causality statement: the event of blood glucose increased is unrelated to breath tek ubt kit. Evaluation summary: follow-up information was received on (b)(6) 2014. The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero. Lab data was unknown. As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown. Lot and expiration date are unknown. The prescribing information (revision: (b)(4) 2013) for breath tek ubt for h. Pylori kit was reviewed by the qm complaint unit. Section 4 (warning and precautions) states the following: "pregnancy. No information is available on use of the pranactin-citric solution during pregnancy". Therefore, the root cause of the reported issue is documentation failure (no information available) regarding the prescribing information. The complaint is confirmed. This case was forwarded to cs & pv for safety review and assigned argus number (b)(4). Based on the product quality complaint investigation results, the root cause of the complaint is "documentation failure" and there is no reported device malfunction. This report from pqc perspective does not meet the requirement for mdr reportability. The complaint type is complaint and ae. This report will be forwarded to safety (cs & pv). This reported issue will be sent to the design project team as part of the monthly reconciliation process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2015-00004 |
| MDR Report Key | 4736135 |
| Report Source | 99 |
| Date Received | 2015-04-07 |
| Date of Report | 2014-02-25 |
| Date Mfgr Received | 2015-03-12 |
| Date Added to Maude | 2015-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. MIRZA RAHMAN |
| Manufacturer Street | 508 CARNEGIE CENTER |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6095359429 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Street | 2440 RESEARCH BLVD. |
| Manufacturer City | ROCKVILLE MD 20850 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20850 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATH TEK UBT KIT |
| Generic Name | UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE |
| Product Code | MSQ |
| Date Received | 2015-04-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Address | ROCKVILLE MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-07 |